QA Specialist, GMP Compliance
2 weeks ago
About the Position:
We are seeking a highly motivated QA Specialist to join our Quality Assurance team at AGC Biologics. This role is responsible for ensuring compliance with current Good Manufacturing Practice (GMP) standards, including EU GMP, 21 CFR, and ICH guidelines.
Key Responsibilities:
- Oversee the Quality Assurance review and approval of technical documents, including Change Controls, Deviations, CAPAs, Risk assessments, SOPs, Validation Plans, Requirements Specifications, Qualification Protocols, and Reports.
- Conduct regular GEMBA walks in GMP areas to ensure adherence to GMP standards.
- Communicate effectively with internal and external stakeholders to resolve and clarify any points of issue.
- Participate in setting standards for Qualification, Calibration, EM, cleaning, and other Facility and engineering activities.
Requirements:
- A science-based degree.
- Experience working in or directly supporting manufacturing operations in a drug substance/product manufacturing site.
- Prior biopharmaceutical experience is desirable.
- Thorough understanding of GMP principles and guidelines.
- Experience with the qualification of GMP facilities, equipment, and computerized systems.
- Knowledge of Data Integrity principles.
- Strong decision-making skills and a proactive attitude.
- Excellent written and verbal communication skills.
- Ability to work efficiently in a fast-paced, matrix environment.
- Ability to meet deadlines and effectively manage multiple tasks.
- Flexibility to adapt to changing business needs and priorities.
About the Department:
The Quality Assurance department consists of over 80 colleagues, with primary responsibilities in Manufacturing, Raw Materials, Quality Control, and Facilities and Equipment. Our main objective is to ensure that our production facilities and laboratories comply with current Good Manufacturing Practice (GMP) standards at all times.
What We Offer:
- An estimated salary of approximately €70,000 - €90,000 per annum, depending on qualifications and experience.
- A dynamic and demanding working environment with opportunities for growth and development.
- Competitive benefits package.
Location: Copenhagen Site
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Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAbout the RoleWe are seeking a highly skilled GMP Compliance Specialist to join our team at AGC Biologics in Copenhagen Site. In this role, you will be responsible for ensuring manufacturing compliance with applicable procedures and guidelines.
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