Pithampur

Experience in IPQA activities for MDI & DPI formulations, including line clearance, sampling, AQL inspection, retention sample management, BMR/BPR review (Pass-X), APQR preparation and cleaning validation document review.

Ensure compliance with FSSAI regulations, guidelines, licensing requirements, and applicable standards.  Manage product registrations, approvals, licenses, renewals, amendments, and regulatory submissions. 

B.Pharm / M.Sc. • Drive analytical method validation and transfer activities while leading a team of 8-10 members..

Piramal's Discovery Solutions (PDS) site in Ahmedabad, India, provide comprehensive drug discovery services, including synthetic chemistry, in vitro biology, in vitro ADME, in vivo pharmacology, DMPK, bioanalytical services, safety and toxicology, route scouting, and non-GMP scale-up.

Downstream processing, TFF system, Buffer preparation; Handling of QMS elements like Change control, Deviation, CAPA, OOS, OOT for downstream process

Liquid syrup manufacturing, paste / ointment manufacturing, liquid syrup filling, CVC bottle filling line, primary and secondary packing, blister packing machine operation, audit exposure in USFDA/EUGMP approved companies. Felix Generics, D.Pharma Apply

Green Field Project -Equipment Qualification & Computer System Validation, HVAC, Water System, Compressed Air, Nitrogen system Qualification & Temperature Mapping.

Workmen allocation and manpower management on shift basis. Supervision of secondary packing operations, especially bottle lines. Compliance with cGMP, safety, and hygiene requirements.

Responsible for development, optimization, and scale-up of tablet formulations, ensuring product quality, stability, and regulatory compliance.