Alvotech er fjölþjóðlegt hátæknifyrirtæki í fremstu röð. Meira en 1400 starfsfólk af um 70 þjóðernum sameinast um að móta framtíðina á sviði líftæknilyfja og tryggja sjúklingum um allan heim betra aðgengi að hágæða lyfjum. Meðal starfsfólks eru margir af færustu vísindamönnum landsins.

Við leyfum fjölbreytileika, forvitni og frumkvæði starfsfólks að njóta sín. Við bjóðum aðlaðandi starfsumhverfi í stöðugri mótun og ögrandi verkefni. Alvotech tryggir að jafnrétti kynjanna til launa og frama nái til alls starfsfólks, hérlendis jafnt sem erlendis. Við viljum laða að okkur færasta fólkið á hverju sviði, án tillits til uppruna eða kyns. Með þessum hætti getum við best þjónað hagsmunum sjúklinga og samstarfsaðilum okkar. 

Vertu með okkur í að bæta lífsgæði fólks og auka aðgengi að hagkvæmum líftæknilyfjum. 


1001-5000

Meginmarkmið jafnlaunavottunar er að vinna gegn kynbundnum launamun og stuðla að jafnrétti kynjanna á vinnumarkaði.

Jafnlaunavottun

Vefsíða

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Hreyfing

Samgöngur

Matur

Skemmtun

Starfsumhverfi

Alvotech &iacute; Reykjav&iacute;k leitar a&eth; &aacute;hugas&ouml;mum einstaklingum til a&eth; ganga til li&eth;s vi&eth; framlei&eth;sluteymi&eth; &iacute; st&ouml;&eth;u hreinsit&aelig;knis.
Sem hreinsit&aelig;knir munt &thorn;&uacute; gegna mikilv&aelig;gu hlutverki vi&eth; a&eth; vi&eth;halda hreinl&aelig;ti &iacute; framlei&eth;slunni hj&aacute; okkur. Hj&aacute; Alvotech st&ouml;rfum vi&eth; &iacute; reglubundnu umhverfi sem krefst umfangsmikillar &thorn;j&aacute;lfunar. Vi&eth; leitum a&eth; einstaklingum sem hafa auga fyrir sm&aacute;atri&eth;um, g&oacute;&eth;a enskukunn&aacute;ttu, g&oacute;&eth;a samskiptah&aelig;fni og &aacute;huga &aacute; &thorn;v&iacute; a&eth; starfa &iacute; teymi.

Starfi&eth; felur me&eth;al annars &iacute; s&eacute;r eftirfarandi
<ul>
<li>
A&eth; vi&eth;halda smitg&aacute;t &iacute; tilgreindum hreinsv&aelig;&eth;um (Grade CNC, D, and C).
</li>
<li>
&Iacute; starfinu felst mikil hreyfing, &thorn;ar &aacute; me&eth;al a&eth; standa og ganga lengi, og a&eth; lyfta hlutum &aacute; &ouml;ruggan h&aacute;tt sem vega &aacute; bilinu 7&ndash;12 kg.
</li>
<li>
A&eth; vinna me&eth; efni af kostg&aelig;fni og nota vi&eth;eigandi hl&iacute;f&eth;arb&uacute;na&eth; (PPE) &iacute; samr&aelig;mi vi&eth; &ouml;ryggisreglur.
</li>
<li>
A&eth; kl&aelig;&eth;ast s&eacute;rst&ouml;kum hl&iacute;f&eth;arfatna&eth;i til a&eth; tryggja ster&iacute;lt vinnuumhverfi.
</li>
</ul>
 Helstu verkefni
<ul>
<li>
Sinna &thorn;rifum &aacute; sv&aelig;&eth;um sem eru undir eftirliti samkv&aelig;mt gildandi g&oacute;&eth;um framlei&eth;sluh&aacute;ttum (cGMP) og flokku&eth;um sv&aelig;&eth;um.
</li>
<li>
&Aacute;byrg&eth; &aacute; birg&eth;ahaldi &aacute; efnum fyrir framlei&eth;slusv&aelig;&eth;i.
</li>
<li>
&Aacute;byrg&eth; &aacute; me&eth;h&ouml;ndlun &uacute;rgangs fr&aacute; framlei&eth;slusv&aelig;&eth;um.
</li>
<li>
&Aacute;byrg&eth; &aacute; a&eth; tryggja a&eth; framlei&eth;slusv&aelig;&eth;i s&eacute;u snyrtileg.
</li>
</ul>
 H&aelig;fniskr&ouml;fur
<ul>
<li>
G&oacute;&eth; enskukunn&aacute;tta b&aelig;&eth;i &iacute; t&ouml;lu&eth;u og ritu&eth;u m&aacute;li.
</li>
<li>
J&aacute;kv&aelig;tt hugarfar og g&oacute;&eth; samskiptah&aelig;fni.
</li>
</ul>

Vinsamlegast athugi&eth; a&eth; um er a&eth; r&aelig;&eth;a vaktavinnu.
Dagvaktir: 06:00-14:00
Kv&ouml;ldvaktir: 13:00-21:00

[English]

Alvotech in Reykjavik is seeking dedicated individuals to join the Manufacturing Team as a Facility Cleaning Specialist.
As a Manufacturing Cleaning Specialist, you will play a crucial role in maintaining the cleanliness and integrity of our state-of-the-art facilities. At Alvotech, we operate in a highly regulated environment, which requires extensive training. We are dedicated to empowering our employees by providing comprehensive support, mentoring, and guidance throughout their journey with us. We are looking for individuals with a keen eye for detail, exceptional English language proficiency, and the ability to effectively communicate and collaborate within a team.

The Position Includes
<ul>
<li>
Suiting up in cleanroom attire to maintain a sterile work environment.
</li>
<li>
Supporting aseptic practices in designated clean areas (Grade CNC, D, and C).
</li>
<li>
This role involves regular movement, including standing and walking for extended periods, and safely lifting items between 15&ndash;25 pounds (7-12 kg).
</li>
<li>
Handling chemicals with care while wearing appropriate personal protective equipment (PPE), as outlined in our safety procedures.
</li>
</ul>
 Scope and Responsibility
<ul>
<li>
Responsible for the cleaning of current Good Manufacturing Practices (cGMP)&nbsp;controlled/classified&nbsp;areas.
</li>
<li>
Responsible for stocking material for the Manufacturing areas.
</li>
<li>
Responsible for taking care of waste from Manufacturing areas.
</li>
<li>
Responsible for ensuring that manufacturing areas are orderly.
</li>
</ul>
 Job Requirements
<ul>
<li>
Excellent command of the English language, both verbal and written, with the ability to communicate fluently and comprehend written instructions.
</li>
<li>
Demonstrate a positive attitude, strong teamwork skills, and the ability to collaborate effectively with colleagues.
</li>
</ul>

Please note that the role involves shift work, weekend work included.
Morning shifts: 6 AM-2 PM
Evening shifts: 1 PM-9 PM

What we offer:
<ul>
<li>
An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
</li>
<li>
The chance to be a part of a global and fast-growing company.
</li>
<li>
An international work culture that encourages diversity, collaboration, and inclusion.
</li>
<li>
Positive, flexible, and innovative work environment.
</li>
<li>
Support for personal growth and internal career development.
</li>
<li>
Company social events and milestone celebrations.
</li>
<li>
Excellent in-house canteen and coffee house.
</li>
<li>
Exercise and well-being support for full-time employees.
</li>
<li>
On-site shower facility.
</li>
<li>
Transportation grant towards eco-friendly modes of travel for full-time employees.
</li>
<li>
Internet at home for full-time employees.
</li>
</ul>
Why Alvotech
We at Alvotech are passionate about improving lives by increasing access to affordable biologics. We&rsquo;re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity, and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work, and empowered to succeed in an agile environment.
True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds, regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let&rsquo;s create a healthier world together through affordable biologic medicines.

Alvotech hf


Alvotech í Reykjavík leitar að áhugasömum einstaklingum til að ganga til liðs við framleiðsluteymið í stöðu hreinsitæknis.

Sem hreinsitæknir munt þú gegna mikilvægu hlutverki við að viðhalda hreinlæti í framleiðslunni hjá okkur. Hjá Alvotech störfum við í reglubundnu umhverfi sem krefst umfangsmikillar þjálfunar. Við leitum að einstaklingum sem hafa auga fyrir smáatriðum, góða enskukunnáttu, góða samskiptahæfni og áhuga á því að starfa í teymi.



Starfið felur meðal annars í sér eftirfarandi


 - 

Að viðhalda smitgát í tilgreindum hreinsvæðum (Grade CNC, D, and C).


 - 

Í starfinu felst mikil hreyfing, þar á meðal að standa og ganga lengi, og að lyfta hlutum á öruggan hátt sem vega á bilinu 7–12 kg.


 - 

Að vinna með efni af kostgæfni og nota viðeigandi hlífðarbúnað (PPE) í samræmi við öryggisreglur.


 - 

Að klæðast sérstökum hlífðarfatnaði til að tryggja sterílt vinnuumhverfi.




Helstu verkefni


 - 

Sinna þrifum á svæðum sem eru undir eftirliti samkvæmt gildandi góðum framleiðsluháttum (cGMP) og flokkuðum svæðum.


 - 

Ábyrgð á birgðahaldi á efnum fyrir framleiðslusvæði.


 - 

Ábyrgð á meðhöndlun úrgangs frá framleiðslusvæðum.


 - 

Ábyrgð á að tryggja að framleiðslusvæði séu snyrtileg.




Hæfniskröfur


 - 

Góð enskukunnátta bæði í töluðu og rituðu máli.


 - 

Jákvætt hugarfar og góð samskiptahæfni.





Vinsamlegast athugið að um er að ræða vaktavinnu.

Dagvaktir: 06:00-14:00

Kvöldvaktir: 13:00-21:00



[English]



Alvotech in Reykjavik is seeking dedicated individuals to join the Manufacturing Team as a Facility Cleaning Specialist.

As a Manufacturing Cleaning Specialist, you will play a crucial role in maintaining the cleanliness and integrity of our state-of-the-art facilities. At Alvotech, we operate in a highly regulated environment, which requires extensive training. We are dedicated to empowering our employees by providing comprehensive support, mentoring, and guidance throughout their journey with us. We are looking for individuals with a keen eye for detail, exceptional English language proficiency, and the ability to effectively communicate and collaborate within a team.



The Position Includes


 - 

Suiting up in cleanroom attire to maintain a sterile work environment.


 - 

Supporting aseptic practices in designated clean areas (Grade CNC, D, and C).


 - 

This role involves regular movement, including standing and walking for extended periods, and safely lifting items between 15–25 pounds (7-12 kg).


 - 

Handling chemicals with care while wearing appropriate personal protective equipment (PPE), as outlined in our safety procedures.




Scope and Responsibility


 - 

Responsible for the cleaning of current Good Manufacturing Practices (cGMP)
controlled/classified
areas.


 - 

Responsible for stocking material for the Manufacturing areas.


 - 

Responsible for taking care of waste from Manufacturing areas.


 - 

Responsible for ensuring that manufacturing areas are orderly.




Job Requirements


 - 

Excellent command of the English language, both verbal and written, with the ability to communicate fluently and comprehend written instructions.


 - 

Demonstrate a positive attitude, strong teamwork skills, and the ability to collaborate effectively with colleagues.





Please note that the role involves shift work, weekend work included.

Morning shifts: 6 AM-2 PM

Evening shifts: 1 PM-9 PM



What we offer:


 - 

An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.


 - 

The chance to be a part of a global and fast-growing company.


 - 

An international work culture that encourages diversity, collaboration, and inclusion.


 - 

Positive, flexible, and innovative work environment.


 - 

Support for personal growth and internal career development.


 - 

Company social events and milestone celebrations.


 - 

Excellent in-house canteen and coffee house.


 - 

Exercise and well-being support for full-time employees.


 - 

On-site shower facility.


 - 

Transportation grant towards eco-friendly modes of travel for full-time employees.


 - 

Internet at home for full-time employees.



Why Alvotech

We at Alvotech are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity, and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work, and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds, regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together through affordable biologic medicines.

Active

Hreinsitæknir / Manufacturing Cleaning Specialist

Vilt &thorn;&uacute; vera hluti af &ouml;flugu teymi &iacute; v&ouml;ruh&uacute;si Alvotech? Vi&eth; leitum af j&aacute;kv&aelig;&eth;um og metna&eth;arfullum einstaklingi til starfa &iacute; v&ouml;ruh&uacute;si&eth; okkar. Starfi&eth; felur &iacute; s&eacute;r m&oacute;tt&ouml;ku, fr&aacute;gang og &ouml;rugga me&eth;h&ouml;ndlun hr&aacute;efna sem notu&eth; eru vi&eth; framlei&eth;slu l&iacute;ft&aelig;knilyfja &iacute; samr&aelig;mi vi&eth; g&aelig;&eth;aferla Alvotech og g&aelig;&eth;asta&eth;la (cGMP). Vinna fer fram &aacute; dag-, kv&ouml;ld- og n&aelig;turv&ouml;ktum.

Umfang og &aacute;byrg&eth;:
<ul>
<li>
M&oacute;ttaka, fr&aacute;gangur og me&eth;h&ouml;ndlun hr&aacute;efna &iacute; samr&aelig;mi vi&eth; g&aelig;&eth;aferla Alvotech og g&aelig;&eth;asta&eth;la (cGMP).
</li>
<li>
&THORN;&aacute;tttaka &iacute; daglegum verkefnum v&ouml;ruh&uacute;ssins &iacute; samvinnu vi&eth; g&aelig;&eth;adeildir Alvotech.
</li>
<li>
A&eth;sto&eth; vi&eth; &uacute;rlausn m&aacute;la sem koma upp er var&eth;a v&ouml;rum&oacute;tt&ouml;ku.
</li>
<li>
Vinna vi&eth; reglulegar v&ouml;rutalningar og almenna birg&eth;ast&yacute;ringu.
</li>
<li>
Taka &thorn;&aacute;tt &iacute; umb&oacute;tavinnu og koma a&eth; ger&eth; vinnul&yacute;singa.
</li>
<li>
&THORN;&aacute;tttaka &iacute; reglulegum &uacute;ttektum sem framkv&aelig;mdar eru af eftirlitsstofnunum.
</li>
</ul>

H&aelig;fniskr&ouml;fur:
<ul>
<li>
Reynsla af starfi &iacute; v&ouml;ruh&uacute;si &aelig;skileg.
</li>
<li>
Reynsla af st&ouml;rfum &iacute; v&ouml;ruh&uacute;si lyfjafyrirt&aelig;kja e&eth;a fyrirt&aelig;kja me&eth; samb&aelig;rilegar g&aelig;&eth;akr&ouml;fur er mikill kostur.
</li>
<li>
Lyftarapr&oacute;f kostur.
</li>
<li>
Frumkv&aelig;&eth;i, n&aacute;kv&aelig;mi og vilji til a&eth; veita g&oacute;&eth;a &thorn;j&oacute;nustu til innri og ytri vi&eth;skiptavina.
</li>
</ul>
[English]
Do you want to be part of a strong and dynamic team in Alvotech&rsquo;s warehouse? We are looking for a positive and ambitious individual to join our warehouse operations. The role includes receiving, handling, and safely managing raw materials used in the production of biopharmaceuticals, in accordance with Alvotech&rsquo;s quality procedures and cGMP standards. Working in day, evening and night shifts is required.

Scope and responsibility:
<ul>
<li>
Assist with all warehouse duties e.g. receiving, storing and handling materials in the warehouse according to Alvotech&acute;s quality procedures and work in accordance to cGMP.
</li>
<li>
Assist running the warehouse working with Quality Assurance and Quality Control.
</li>
<li>
Assist with troubleshooting any issues with deliveries
</li>
<li>
Support inventory discrepancies through cycle counts and root cause investigations
</li>
<li>
Provide support and business improvements for written procedures, SOPs etc.
</li>
<li>
Contribute as required to regular Audits and any other interactions with regulatory agencies.
</li>
</ul>

Job requirements:
<ul>
<li>
Warehouse experience and cGMP experience preferred due to operational needs.
</li>
<li>
Warehouse experience preferably in the Pharmaceutical manufacturing industry or in a similarly regulated industry would be advantageous.
</li>
<li>
Certification to operate a forklift would be advantageous.
</li>
<li>
Demonstrate a can do attitude. Customer service skills with internal/ external stakeholders. Due diligent with an eye for detail.
</li>
</ul>

What we offer:
<ul>
<li>
An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
</li>
<li>
The chance to be a part of a global and fast-growing company.
</li>
<li>
An international work culture that encourages diversity, collaboration, and inclusion.
</li>
<li>
Positive, flexible, and innovative work environment.
</li>
<li>
Support for personal growth and internal career development.
</li>
<li>
Company social events and milestone celebrations.
</li>
<li>
Excellent in-house canteen and coffee house.
</li>
<li>
Exercise and well-being support for full-time employees.
</li>
<li>
On-site shower facility.
</li>
<li>
Transportation grant towards eco-friendly modes of travel for full-time employees.
</li>
<li>
Internet at home for full-time employees.
</li>
</ul>


Vilt þú vera hluti af öflugu teymi í vöruhúsi Alvotech? Við leitum af jákvæðum og metnaðarfullum einstaklingi til starfa í vöruhúsið okkar. Starfið felur í sér móttöku, frágang og örugga meðhöndlun hráefna sem notuð eru við framleiðslu líftæknilyfja í samræmi við gæðaferla Alvotech og gæðastaðla (cGMP). Vinna fer fram á dag-, kvöld- og næturvöktum.



Umfang og ábyrgð:


 - 

Móttaka, frágangur og meðhöndlun hráefna í samræmi við gæðaferla Alvotech og gæðastaðla (cGMP).


 - 

Þátttaka í daglegum verkefnum vöruhússins í samvinnu við gæðadeildir Alvotech.


 - 

Aðstoð við úrlausn mála sem koma upp er varða vörumóttöku.


 - 

Vinna við reglulegar vörutalningar og almenna birgðastýringu.


 - 

Taka þátt í umbótavinnu og koma að gerð vinnulýsinga.


 - 

Þátttaka í reglulegum úttektum sem framkvæmdar eru af eftirlitsstofnunum.





Hæfniskröfur:


 - 

Reynsla af starfi í vöruhúsi æskileg.


 - 

Reynsla af störfum í vöruhúsi lyfjafyrirtækja eða fyrirtækja með sambærilegar gæðakröfur er mikill kostur.


 - 

Lyftarapróf kostur.


 - 

Frumkvæði, nákvæmi og vilji til að veita góða þjónustu til innri og ytri viðskiptavina.



[English]

Do you want to be part of a strong and dynamic team in Alvotech’s warehouse?
We are looking for a positive and ambitious individual to join our warehouse operations. The role includes receiving, handling, and safely managing raw materials used in the production of biopharmaceuticals, in accordance with Alvotech’s quality procedures and cGMP standards. Working in day, evening and night shifts is required.



Scope and responsibility:


 - 

Assist with all warehouse duties e.g. receiving, storing and handling materials in the warehouse according to Alvotech´s quality procedures and work in accordance to cGMP.


 - 

Assist running the warehouse working with Quality Assurance and Quality Control.


 - 

Assist with troubleshooting any issues with deliveries


 - 

Support inventory discrepancies through cycle counts and root cause investigations


 - 

Provide support and business improvements for written procedures, SOPs etc.


 - 

Contribute as required to regular Audits and any other interactions with regulatory agencies.





Job requirements:


 - 

Warehouse experience and cGMP experience preferred due to operational needs.


 - 

Warehouse experience preferably in the Pharmaceutical manufacturing industry or in a similarly regulated industry would be advantageous.


 - 

Certification to operate a forklift would be advantageous.


 - 

Demonstrate a can do attitude. Customer service skills with internal/ external stakeholders. Due diligent with an eye for detail.





What we offer:


 - 

An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.


 - 

The chance to be a part of a global and fast-growing company.


 - 

An international work culture that encourages diversity, collaboration, and inclusion.


 - 

Positive, flexible, and innovative work environment.


 - 

Support for personal growth and internal career development.


 - 

Company social events and milestone celebrations.


 - 

Excellent in-house canteen and coffee house.


 - 

Exercise and well-being support for full-time employees.


 - 

On-site shower facility.


 - 

Transportation grant towards eco-friendly modes of travel for full-time employees.


 - 

Internet at home for full-time employees.



Starfsfólk í vöruhús / Warehouse Operator

Alvotech leitar a&eth; metna&eth;arfullum s&eacute;rfr&aelig;&eth;ingi til a&eth; ganga til li&eth;s vi&eth; teymi&eth; okkar. &Iacute; &thorn;essu hlutverki munt &thorn;&uacute; sty&eth;ja vi&eth; starfsemi &iacute; framlei&eth;slu l&iacute;ft&aelig;knilyfja, tryggja a&eth; fari&eth; s&eacute; eftir cGMP‑st&ouml;&eth;lum og leggja &thorn;itt af m&ouml;rkum til st&ouml;&eth;ugra umb&oacute;ta &iacute; framlei&eth;sluumhverfinu. Vi&eth; leitum a&eth; lausnami&eth;u&eth;um einstaklingi sem n&yacute;tur &thorn;ess a&eth; starfa &iacute; fj&ouml;lbreyttu og krefjandi vinnuumhverfi og hefur &aacute;huga &aacute; a&eth; vi&eth;halda h&aacute;marks g&aelig;&eth;um og reglufylgni.

[English]

Alvotech is seeking a dedicated and detail‑oriented Control Operations Specialist to join our team. In this role, you will support key quality operations within biomanufacturing, ensure adherence to cGMP standards, and contribute to continuous improvement across our production environment. We are looking for someone who thrives in a dynamic setting, enjoys problem‑solving, and is committed to maintaining the highest standards of quality and compliance.

Key Responsibilities
<ul>
<li>
Initiating deviation and performing investigations for deviation reported in Manufacturing.
</li>
<li>
Assisting in creating and reviewing documents such as Standard Operating.
</li>
<li>
Owning Deviations Handling (Non-process, system/facility, and utility related), CAPAs, change controls and Change actions.
</li>
<li>
Trending DEVs in MFG and identifying the Areas for improvement.
</li>
<li>
Develop and maintain metrics to track batch records and deviation turnaround time and assess areas of improvement.
</li>
<li>
Review facility-related risk assessment, EMI deviations and EM trend reports.
</li>
<li>
Providing compliance oversight during biomanufacturing runs including Oversee cGMP activities within DPM production areas (Grade A, B, C and CNC).
</li>
<li>
Troubleshooting and review and approval of quality documents such as planned changes.
</li>
<li>
Tracking and support on-time closure of Quality Records and maintaining compliance against KPIs for the below Quality Records.
</li>
<li>
Effectiveness checks applied for Quality Records.
</li>
<li>
Performing monthly EHS inspection on the production floor.
</li>
<li>
Supporting the review of process logbooks and other GMP records in Manufacturing.
</li>
<li>
Conducting routine facility walkthrough and ensuring that the manufacturing area is maintained in a state of compliance and inspection readiness.
</li>
<li>
Contribute as required to regular audits, and interactions with regulatory agencies.
</li>
</ul>
&nbsp;
Qualifications
<ul>
<li>
Degree/Diploma in related discipline or sufficient relevant experience.
</li>
<li>
Knowledge in DP operations is additional benefit to this role.
</li>
<li>
Knowledge of regulatory guidelines for biomanufacturing (FDA, ICH, PIC/s) and implementation.
</li>
<li>
Minimum 3 years in compliance role for biomanufacturing, desired.
</li>
<li>
Experience in supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies including the FDA and EMA.
</li>
<li>
Expertise working with up-to-date cGMP compliance and associated documentation.
</li>
</ul>

What we offer:&nbsp;
<ul>
<li>
An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.&nbsp;
</li>
<li>
The chance to be a part of a global and fast-growing company.&nbsp;
</li>
<li>
An international work culture that encourages diversity, collaboration and inclusion.&nbsp;
</li>
<li>
Positive, flexible, and innovative work environment.&nbsp;
</li>
<li>
Support for personal growth and internal career development.&nbsp;
</li>
<li>
Company social events and milestone celebrations.&nbsp;
</li>
<li>
Excellent in-house canteen and coffee house.&nbsp;
</li>
<li>
Exercise and wellbeing support for full-time employees.&nbsp;
</li>
<li>
On-site shower facility.&nbsp;
</li>
<li>
Transportation grant towards eco-friendly modes of travel for full-time employees.&nbsp;
</li>
<li>
Internet at home for full-time employees. &nbsp;
</li>
</ul>
Why Alvotech&nbsp;
At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We&rsquo;re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.&nbsp;
True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let&rsquo;s create a healthier world together, through affordable biologic medicines.&nbsp;


Alvotech leitar að metnaðarfullum sérfræðingi til að ganga til liðs við teymið okkar. Í þessu hlutverki munt þú styðja við starfsemi í framleiðslu líftæknilyfja, tryggja að farið sé eftir cGMP‑stöðlum og leggja þitt af mörkum til stöðugra umbóta í framleiðsluumhverfinu. Við leitum að lausnamiðuðum einstaklingi sem nýtur þess að starfa í fjölbreyttu og krefjandi vinnuumhverfi og hefur áhuga á að viðhalda hámarks gæðum og reglufylgni.



[English]



Alvotech is seeking a dedicated and detail‑oriented Control Operations Specialist to join our team. In this role, you will support key quality operations within biomanufacturing, ensure adherence to cGMP standards, and contribute to continuous improvement across our production environment. We are looking for someone who thrives in a dynamic setting, enjoys problem‑solving, and is committed to maintaining the highest standards of quality and compliance.



Key Responsibilities


 - 

Initiating deviation and performing investigations for deviation reported in Manufacturing.


 - 

Assisting in creating and reviewing documents such as Standard Operating.


 - 

Owning Deviations Handling (Non-process, system/facility, and utility related), CAPAs, change controls and Change actions.


 - 

Trending DEVs in MFG and identifying the Areas for improvement.


 - 

Develop and maintain metrics to track batch records and deviation turnaround time and assess areas of improvement.


 - 

Review facility-related risk assessment, EMI deviations and EM trend reports.


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Providing compliance oversight during biomanufacturing runs including Oversee cGMP activities within DPM production areas (Grade A, B, C and CNC).


 - 

Troubleshooting and review and approval of quality documents such as planned changes.


 - 

Tracking and support on-time closure of Quality Records and maintaining compliance against KPIs for the below Quality Records.


 - 

Effectiveness checks applied for Quality Records.


 - 

Performing monthly EHS inspection on the production floor.


 - 

Supporting the review of process logbooks and other GMP records in Manufacturing.


 - 

Conducting routine facility walkthrough and ensuring that the manufacturing area is maintained in a state of compliance and inspection readiness.


 - 

Contribute as required to regular audits, and interactions with regulatory agencies.






Qualifications


 - 

Degree/Diploma in related discipline or sufficient relevant experience.


 - 

Knowledge in DP operations is additional benefit to this role.


 - 

Knowledge of regulatory guidelines for biomanufacturing (FDA, ICH, PIC/s) and implementation.


 - 

Minimum 3 years in compliance role for biomanufacturing, desired.


 - 

Experience in supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies including the FDA and EMA.


 - 

Expertise working with up-to-date cGMP compliance and associated documentation.





What we offer:



 - 

An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.



 - 

The chance to be a part of a global and fast-growing company.



 - 

An international work culture that encourages diversity, collaboration and inclusion.



 - 

Positive, flexible, and innovative work environment.



 - 

Support for personal growth and internal career development.



 - 

Company social events and milestone celebrations.



 - 

Excellent in-house canteen and coffee house.



 - 

Exercise and wellbeing support for full-time employees.



 - 

On-site shower facility.



 - 

Transportation grant towards eco-friendly modes of travel for full-time employees.



 - 

Internet at home for full-time employees.





Why Alvotech


At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.


True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.
