Quality Assurance Specialist in Biopharmaceutical Manufacturing
4 weeks ago
About the Role:
As a Quality Assurance Specialist at AGC Biologics, you will play a critical role in ensuring the highest quality standards are met in our biopharmaceutical manufacturing processes. Located at our Copenhagen Site, this position offers an exciting opportunity to contribute to the development of life-changing therapies for patients worldwide.
Main Responsibilities:
- Providing on-site quality support during production, ensuring compliance with procedures and GMP requirements;
- Performing QA sign-offs after set-up to confirm manufacturing line setup meets batch documentation and SOP requirements;
- Conducting batch record stage approvals as part of the batch release process;
- Participating in Gemba walks and conducting site system audits according to the agreed schedule;
- Reviewing and approving validation/qualification documentation;
- Liaising with production management to resolve batch documentation issues;
- Driving improvements in GMP compliance across all shifts;
- Supporting manufacturing during batch review with Good Documentation Practice-related queries;
- Performing quality reviews and approvals of deviations, change controls, and CAPAs;
- Reviewing and approving buffer and media MPR documents.
Requirements:
- Bachelor's and/or Master's degree in Natural Sciences or certified laboratory technician with relevant experience;
- 3-5 years of experience within a GMP environment in the Pharma Industry, preferably in biopharma;
- Strong knowledge of BPR/MPR review principles and GMP guidelines;
- Excellent written and verbal communication skills for internal and external stakeholders;
- Ability to work in a fast-paced matrix environment, prioritizing tasks and meeting deadlines;
- Flexibility to adapt to changing business needs and priorities.
About You:
We're looking for someone who is detail-oriented, proactive, and passionate about ensuring the highest quality standards in biopharmaceutical manufacturing. As a strong decision-maker with excellent communication skills, you'll be able to effectively collaborate with cross-functional teams and drive improvements in GMP compliance.
What We Offer:
A competitive salary range of approximately €55,000 - €70,000 per year, depending on qualifications and experience. Additionally, we offer a dynamic and supportive work environment, opportunities for professional growth and development, and a comprehensive benefits package.
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