Job profile description:
- Candidates must have experience in preparation and handling of BMR/BPR/APQR
- Candidate worked regulatory setting like WHO-GMP, MHRA,EU-GMP etc.
- Candidates must have experience FDA license registration process
- Candidates must have experience in dossiers preparation.
- Candidates must have experience in handling of change control, deviations, Incidants OOS/OOT, CAPA etc.
- Candidates must have experience in preparation and implementation of documents like SOP, STP, Specification, Protocols etc.
- Candidate should have experience on analysis of pharmaceutical finished product such as solid, liquid and semisolid dosage form in GMP environment.
- Candidate well-versed LIMS /SAP systems.
- Preparing and updating master documentation including batch documents.
- Handling of Market Complaints.
- Internal audit and related activities and compliance report.
- Well versed with IPQA functions