Job Description:
- Preparation of Documents related to Technology Transfer, Batch, Protocols of Qualification, Scale-up/Registration, etc
- Preparing and issue of site variations and Query response docs.
- Maintaining a record of Licences- Test/Manufacturing, Punch change part procurements, MFC
- To ensure proper transfer of Documents to Plant QA from R&D
- To review and approve change control, deviations and implementation of changes to meet the compliance
- To co-ordinate predefined frequencies calibration for IPQA instrument & Equipment
- Impart training to F&D team members on various aspects of GMP/GLP guidelines and practices
- To co-ordinate predefined frequencies calibration for IPQA instrument & analytical Equipment’s and its periodic Review
- Preparation of SOPs/Department Manuals, Formulation department manual and its issuance and its archival
- To review periodically lab not book for the experiment carried out in labs
- Maintenance of IQ, OQ, and PQ, manuals of equipment/ instruments and update
- innovator sample management
- Review the audit findings observations recommendations given in the audit report for compliance
Qualification: Appropriately Qualified
Experience: 2-5 Years
Job Location: Panjim, Goa
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