Biopharmaceutical Quality Assurance Specialist
1 week ago
At AGC Biologics, we strive to improve life quality by bringing new biopharmaceuticals to market. Our mission is to work side by side with our customers to create a healthier and happier tomorrow.
Quality Assurance Scientist Role OverviewWe are seeking a self-motivated Quality Assurance Scientist to maintain a commitment to quality in our dynamic working environment. This individual will oversee the review and approval of technical documents, conduct GEMBA walks, communicate with stakeholders, and set standards for qualification, calibration, and facility activities.
Daily Responsibilities- Oversee the review and approval of technical documents, including Change Controls, Deviations, CAPAs, Risk Assessments, SOPs, Validation Plans, Requirements Specifications, Qualification Protocols, and Reports.
- Conduct GEMBA walks in GMP areas to ensure compliance with current Good Manufacturing Practice (GMP) standards.
- Communicate with internal and external stakeholders to resolve and clarify any points of issue.
- Set standards for Qualification, Calibration, EM, cleaning, and other Facility and engineering activities.
We are looking for a science-based degree holder with experience working in or directly supporting manufacturing operations in a drug substance/product manufacturing site. Prior biopharmaceutical experience is desirable. You should have a thorough understanding of Good Manufacturing Practice (GMP) principles and guidelines, as well as experience with the qualification of GMP facilities, equipment, and computerized systems.
You should also possess knowledge of Data Integrity principles, strong decision-making skills, and a proactive attitude. Excellent written and verbal communication skills are essential, along with the ability to work efficiently in a fast-paced, matrix environment. Flexibility to adapt to changing business needs and priorities is also required.
Proficiency in both written and spoken English is necessary, as we serve international clients and English is our company language.
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