QA制剂专员

About the Role:
As a QA Specialist in Drug Product Manufacturing, you will play a pivotal role in ensuring the quality and compliance of our drug product manufacturing processes. You will contribute to maintaining high standards of operational excellence by overseeing production activities, managing deviations, and ensuring adherence to GMP regulations. This position offers an opportunity to work in a dynamic environment where your expertise will directly support BioNTech’s mission of pioneering immunotherapies for serious diseases.

Your Contribution:

• Supervise key drug product manufacturing processes, including weighing, solution preparation, vial washing, filling, capping, labeling, packaging, cleaning/disinfection, line clearance, and storage
• Review and approve SOPs related to drug product manufacturing operations
• Support the optimization of quality management documents for drug product production
• Audit production data and batch records to ensure accuracy and compliance
• Review deviations, change controls, CAPAs; participate in OOS investigations
• Oversee the release of drug products and handle non-conforming materials during production
• Manage clinical drug returns and ensure proper handling procedures are followed
• Address product complaints, returns, and recalls effectively
• Monitor environmental conditions in manufacturing areas and confirm alarms as needed
• Assist with material release processes and supplier qualification related to drug product manufacturing
• Collaborate on technical transfers for drug product manufacturing processes

A Good Match:

• 3–5 years of experience in pharmaceutical quality management or related fields; prior QA experience in drug product manufacturing is preferred
• Familiarity with aseptic processing and biological drug production is an advantage
• Strong knowledge of Chinese GMP regulations and pharmaceutical quality management systems
• In-depth understanding of drug product manufacturing workflows and on-site quality requirements
• Skilled in managing deviations, change controls, CAPAs, batch record reviews, and other quality-related activities
• Excellent communication and problem-solving skills with a detail-oriented mindset; capable of working effectively in a production environment
• Proficiency in English (CET-4 or above), with the ability to read technical documents and quality files

Join us at BioNTech as we strive to transform lives through innovative therapies. If you are passionate about quality assurance in pharmaceutical manufacturing and thrive in a fast-paced environment dedicated to excellence—this role is for you!