Regulatory Affairs Officer

About the client:PSShas been mandated to hire aHead of Regulatory Affairsfor a leading R&D backed, manufacturing women's health organization with operations in over 140 countries worldwide. It is the world's largest manufacturer of Contraceptives devices.Job PurposeThe Head of Regulatory Affairs will lead global regulatory strategies for medical devices and...

Position: Production Officer Location: Bhimpore, Daman Industry: Pharma - Sterile Injectable Plant Experience: 4-5 years Education: B.Pharm CTC: 5.5 to 6 (Gross) Essential Areas of Knowledge / Skills: He should have hands on experience in greenfield and brownfield project for sterile Injectable manufacturing facility with exposure of isolator technology &...

The QC Micro – Environmental Monitoring Officer will be responsible for performing environmental monitoring and microbiological testing to ensure that all production and laboratory areas comply with GMP and regulatory standards. This role ensures the safety and quality of pharmaceutical products by monitoring microbial contamination levels and maintaining...

The Senior Officer – QC (Raw Material) will be responsible for testing and analysis of raw materials to ensure compliance with pharmacopeial standards (USP, BP, IP) and GMP regulations.Key Responsibilities: Raw Material Testing: Perform physicochemical and instrumental analysis (HPLC, GC, UV, FTIR, Titrations) of raw materials and excipients. Compliance &...

Conduct stability analysis (routine/accelerated) of OSD products.Operate & calibrate instruments (HPLC, GC, Dissolution, UV, etc.).Maintain documentation, raw data, and stability records (ALCOA+ compliance).Handle OOS/OOT, deviations, and support audits.Follow SOPs, safety, and regulatory guidelines.Handle OOS/OOT, deviations, and support audits.Follow SOPs,...

Review BMR/BPREnsure cGMP/SOP compliancePerform line clearance and in-process checksHandle deviations/CAPA/change controlsMaintain QA documentationSupport audits and regulatory inspectionsCall on /

**Location**: Daman & Diu **Experience**: 2-5 Years **Must-Have**: Hands-on experience in any Pharma Industry. **JD**: Analytical method validation, method verification, method transfer and mass balance study of various finished products and APIs using respective protocol on HPLC instrument. 2 Stability samples analysis on HPLC instrument 3 Experienced...

Sterile Manufacturing Operations: Oversee aseptic filling, compounding, filtration, and lyophilization processes to ensure product sterility and quality. Aseptic Practices & Compliance: Ensure adherence to GMP, USFDA, MHRA, WHO, and EU-GMP guidelines, maintaining sterility assurance in cleanroom environments. Process Monitoring & Validation: Perform...

Assist in line clearance, in-process checks, and sampling during OSD manufacturing and packing.Learn real-time review of Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs).Support QA officers in monitoring GMP practices, documentation accuracy, and data integrity.Observe and understand deviation reporting, change control, and CAPA...

Validation Officer - Pharmaceutical Location: Daman & Diu Experience: 2-5 Years Must-Have: Hands-on experience in any Pharma Industry. JD: Analytical method validation, method verification, method transfer and mass balance study of various finished products and APIs using respective protocol on HPLC instrument. 2 Stability samples analysis on HPLC...