Drug Product Senior Specialist, Nantong-QA

About the role:

As a Drug Product Senior Specialist in Nantong QA, you’ll oversee on-site quality for drug product manufacturing. You’ll help ensure production activities meet GMP requirements and company quality standards, supporting compliant operations and product release.

Working with Production, QC and Engineering, you’ll oversee manufacturing activities, review batch records and quality documents, and support investigations, audits and inspections. Your work will help teams identify quality risks and address them in a timely manner.

Your contribution:

• Oversee drug product manufacturing activities, including solution preparation, filtration, filling, packaging, cleaning and disinfection, and line clearance, to ensure compliance with GMP and company quality standards
• Review batch production records and related documents for completeness, accuracy and compliance
• Participate in investigations and resolution of deviations, change controls and corrective and preventive actions
• Review and improve production procedures, batch records and other quality documents
• Support product release by ensuring required documentation reviews are complete
• Participate in internal and customer audits and regulatory inspections, and help implement corrective actions

A good match:

• Bachelor’s degree or higher in bioengineering, biotechnology, pharmacy, chemistry or a related field
• Experience in pharmaceutical manufacturing quality management, ideally with on-site QA experience in drug product production
• Knowledge of China GMP regulations, pharmaceutical quality management systems and drug product manufacturing processes
• Familiarity with deviation investigations, change controls, corrective and preventive actions, and batch record review
• Experience in on-site QA for aseptic processing, fill-finish or biologics manufacturing is an advantage
• Strong communication and problem-analysis skills, a responsible and detail-oriented approach, and CET-4 English proficiency or above, with the ability to read English quality and technical documents