4-5

Manage product registrations, renewals, variations and lifecycle activities. Review SmPC, PIL, artworks, labels and other regulatory documents.

APDM Pharmaceuticals Private Limited has its office in Ahmedabad with all QA and regulatory support staffs for managing CDO and CDMO projects,vendor Audits, BA BA monitoring, project and Engg team.

Performing real-time monitoring of manufacturing and packaging operations to ensure adherence to established processes.

B.Pharm / M.Sc. - Review analytical & electronic QC data with tight QMS grip on incidents, OOS & OOT.

ITI / Diploma for Operators (Sterile USFDA Exp.) B.Pharm / M.Pharm for Officer (Sterile USFDA Exp.)

Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts, Clinical Research Associate at Sun Pharma

Looking for Supervisor and Operators with Injectable Aseptic Area / Terminal Sterilization Packing experience in Manufacturing.

Execute routine & stability testing of pharmaceutical products. Ensure compliance with WHO-GMP, SOPs & regulatory requirements.

QMS & Audit Compliance: Implementation and maintenance of QMS, document control, internal audits, audit preparation, inspection support and CAPA follow-up.