Description:
- Review and approve change controls, corrective and preventive actions (CAPAs), deviations including investigation protocols, root cause analysis and final investigation reports.
- Review and approve batch records
- Review and approval of Equipment qualification including IOQ and PQ, process validation, development studies, hold time studies etc.
- Provide quality assurance support across functional and cross-functional forums.
- Oversee quality aspects of material and supplier management, including preparation of material qualification packages, supplier audit assessments, and maintenance of the supplier management system.
- Collaborate with stakeholders such as Quality Control (QC), Manufacturing Science & Technology (MS&T), Engineering, and Warehouse to develop, review, and maintain documentation and quality records throughout the product lifecycle (e.g., method validations, facility upgrades, qualification protocols, calibration records).
- Review and approve Good Manufacturing Practice (GMP) documentation and data to ensure accuracy, completeness, and compliance.
- Partner cross-functionally to support timely delivery of project milestones.
Contribute to the identification, development, and execution of continuous improvement
Education
- Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Engineering or Supply Chain in a relevant discipline.
- 5 to 8 years’ experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.