Job Description
Key Responsibilities:
- Participate in the review of technical documents related to technology transfer, ensuring the transfer process meets quality requirements and is implemented smoothly.
- Responsible for master batch record review to ensure related documents, processes, and procedures comply with company policies and regulatory requirements.
- Execute batch record review, verifying production records for completeness, accuracy, and compliance.
- Review quality standards and analytical methods to ensure their scientific validity and compliance with regulatory requirements.
- Review process validation master plans (VMP), validation protocols, and validation reports to ensure validation activities comply with company and regulatory standards.
- Lead change control and deviation management related to projects, driving deviation investigations, corrective actions, and preventive measures.
- Responsible for product release, ...