QC Raw Materials Scientist

We are looking for an individual that has a positive attitude, embraces challenges, is flexible and adaptive and shares our values of team spirit and team efforts.

A scientist within the Quality Control Incoming Material testing team plays a vital part at Alvotech by contributing to testing and ensuring the compliance of incoming and raw materials released for use in the manufacturing process of our products at Alvotech. Alvotech operates in a highly regulated environment that requires attention to detail and thoroughness.

Key Responsibilities:

• Performs analytical testing of raw and incoming GxP materials used in the manufacturing process at Alvotech, with various techniques such as compendial methods, FTIR etc.
• Knowledge of compendia and testing methodology within
• Review and interpretation of test results in compliance with pharmacopeial standards and internal procedures, following GDP standards.
• Support verification, validation and troubleshooting of analytical techniques
• Performing routine cleaning, verification, stock checks and upkeep of laboratory and equipment
• Performing other activities required to support testing, e.g. solution preparation.
• Participate and make positive contributions to team meetings.
• Participate in the creation, maintenance and review of quality documents within the Quality management system.
• Proactively ensure the QC Incoming Material testing laboratory is maintained in a state of Inspection readiness.
• Supports deviations, CAPAs, document change controls and Change controls relating to incoming material testing
• Supports laboratory investigations
• Be able to work in accordance with GxP practices, conducting all activities in a compliant manner.
• Responsible for adhering to all relevant Alvotech policies and procedures.

Qualifications:

• Bachelor´s or Master’s Degree in a relevant scientific discipline (e.g., chemistry, biotechnology, biochemistry, pharmaceutical sciences or related field) and preferably relevant experience in pharmaceutical or biopharmaceutical sector.

• Attention to detail, thoroughness, and willingness to learn is a desired attribute.

• Proficient in use of a PC and common Microsoft packages such as Word and Excel.

• Understanding and review of electronic data from instrument software.

• Knowledge of Good Manufacturing Practices (GMP) and Documentation Rules is an asset.

• Ability to work with flexibility in a changing and demanding environment.

• Ability to work under pressure within tight deadlines and solving issues as they arrive with minimal supervision.