Daman

 IPQA Mfg. & Packing, Shop floor activities, Review of equipment audit trails, BMR, BPR review, line clearance. Process Validation, equipment, Utility qualification.

M.Sc / B.Pharma / M.Pharma ; 2 to 8 years of experience into API / Intermediates Manufacturing.

Candidate should have experience in Oral formulations Solid and liquid for Handling of IPQA, APQR activity and Process Validation. Candidates must have experience in review of Analytical Document, Investigating out-of-specification results, and ensuring adherence to GMP guidelines.

Candidate should have experience in Oral formulations Solid and liquid for Handling of APQR, IPQA activity and Process Validation. Candidate should have experience in regulatory plant with hand on experience in Raw Material and Packing Material in formulation unit.

Experience in Pharmaceutical Company in Parental, responsible for line clearance activity, responsible for in process checks, responsible for sampling. Finished product checking before release, management and execution of process validation & media fill simulation.

FP / Stability / Analytical Instrumentation-HPLC, UV and Dissolution; Handling of LIMS, Empower software, HPLC Waters; IPQA Mfg. and Packing, Shop floor activities. Review of equipment audit trails / BMR, BPR review / line clearance. Handling of CAPA / EC and External Audits USFDA/MHRA/Germany

Candidate should have experience in regulatory plant USFDA/ MHRA approved, having exposure of Blister, Strip and bulk Packaging Primary and Secondary, Track and Trace with serialization system and have operation knowledge of in Oral formulations in packing section.

FP / Stability / Analytical Instrumentation-HPLC, UV and Dissolution. Handling of LIMS, Empower software, HPLC Waters and SAP. Granulation Integrated line, Make-GEA / Glatt; Compression KORSCH, SEJONG, GEA, CADMACH; Capsule Filling; Liquid Manufacturing area

2-8 years into receipt & dispensing activity, inward & outward activity. 2 to 8 years of experience into API / Intermediates Manufacturing. 2-5 years of experience in Granulation, Coating, Compression, Blister Secondary and Cartonator, Bulk Secondary