Posted:1 week ago|
Platform:
Work from Office
Full Time
Responsible in preparing customer files, review batch records, and release batch records. Liaison to our customer's quality assurance groups for batch record review and release. Manage the communication between the operations/production, project management, and other quality groups. Approve all batch records prior to production to ensure that they conform to requirements of cGMP
- Batch release procedure
- Document and data control
- Handling of OOS, CAPA, Incident, Change control etc.
- Plant round and IPQA activity
- GMP and 21 CFR activity
- Data integrity policy
- APQR Preparation
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