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 setting.
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