QA Manager Material Management

3 days ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

About the Job

As a Quality Assurance Scientist at AGC Biologics, you will support Supply Chain, Process Transfer, and QC for late-stage and commercial products.

Key responsibilities include closing collaborations with internal stakeholders, change control, deviation handling, and CAPAs, reviewing and approving material specifications, releasing raw materials and disposables, and collaborating with other departments to ensure effective quality-related activities according to cGMP standards.

This role requires proven experience in QA and/or material management, along with requirements for commercial and/or late-state clinical phase GMP manufacturing of biological intermediates, APIs, and Cell Banks.

You will also need QA oversight and guidance of staff, experience with contract manufacturing, business understanding, deviation handling including root cause investigations, and review and evaluation of cGMP documentation.

A bachelor's degree in a relevant field, such as pharmacy, biotechnology, biology, or chemistry, is required.

A self-motivating personality with a pragmatic approach to daily work is essential, as is the ability to find solutions, deliver on promises, and provide a positive customer experience.

Communication skills are critical, particularly in written and spoken English, due to our international clientele and company language.



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