
Alvotech hf
Alvotech er fjölþjóðlegt hátæknifyrirtæki í fremstu röð, þar sem yfir 1000 starfsmenn af um 64 þjóðernum vinna að því að móta framtíðina á sviði líftæknilyfja og auka aðgengi sjúklinga um allan heim að hágæða lyfjum. Margir af færustu vísindamönnum landsins starfa hjá fyrirtækinu.
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 allra starfsmanna, 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.

QA specialist
We are seeking a highly motivated and experienced QA Specialist to join our Quality Assurance team. The successful candidate will be Independent in assignments. Routinely leads projects and/or supervises small or medium-sized teams of technicians or admin. Performs both routine tasks within procedures and processes and non-routine tasks. Take part in large projects. Challenges and decisions are discussed, made and solved in cooperation with supervisor/other employees. Can make adjustments/changes to procedures, processes, and projects.
Helstu verkefni og ábyrgð
- Working as a QA contact person with DSM and DPM.
- Provide general QA expertise and support for DSM and DPM.
- Provide QA expertise during the investigations of Deviations, Risk Assessments, OOS; and QA approve these and their related CAPAs.
- Support and approve Change Control records.
- Participate in CAPAs resolution of inspection findings.
- QA review and approval of batch records and associated documents from DSM and DPM.
- QA review and approval of product specifications and master batch records.
- QA review and approval of records and reports related to area of responsibility.
- QA review and approval of Standard Operating Procedures (SOPs) related to area of responsibility.
- Contribute to the preparation of inspections as per defined and agreed role.
- Train new members of the QA Operations (DSM and DPM) team and other employees as needed.
- Participate in continuous improvement of the Quality Management System.
Menntunar- og hæfniskröfur
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field (or equivalent experience).
- Previous experience in a quality assurance role within the pharmaceutical or biotechnology industry is preferred.
- Strong understanding of GMP, EMA, FDA regulations, and industry standards is preferred.
- Strong communication and interpersonal skills to effectively work with cross-functional teams.
- The ability to work independently and effectively prioritize tasks in a fast-paced environment.
- Proficiency in English, written and spoken.
Auglýsing birt16. apríl 2025
Umsóknarfrestur7. maí 2025
Tungumálahæfni

Nauðsyn
Staðsetning
Sæmundargata 15-19 15R, 101 Reykjavík
Starfstegund
Starfsgreinar
Starfsmerkingar
Fleiri störf (5)
Sambærileg störf (8)

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