31 Jul
|
East African India Overseas
|
Uttarakhand
31 Jul
East African India Overseas
Uttarakhand
Dear Candidates,
Please find below the company profile and JD :
Job Posting Production Manager (Ophthalmic / Liquid & Dry Powder Injectables)
Location: Selaqui, Dehradun, Uttarakhand
Industry: Pharmaceutical Contract Manufacturing (CDMO/CMO)
Department: Production
Experience: 12- 18 Years
Qualification: B.Pharm / M.Pharm / M.Sc (Chemistry)
Position: Production Manager
About the Role
We are seeking an experienced Production Manager to lead manufacturing operations for Ophthalmic Sterile Products, Liquid Injectables, and Dry Powder Injectables. The ideal candidate should have extensive exposure to sterile manufacturing, aseptic processing, production planning, regulatory compliance, and team leadership in a WHO-GMP/USFDA-approved pharmaceutical manufacturing setting.
Key Responsibilities
- Manage end-to-end production activities for Ophthalmic, Liquid Injection, and Dry Powder Injection manufacturing.
- Ensure compliance with cGMP, WHO-GMP, Schedule M, EU-GMP, and other applicable regulatory guidelines.
- Plan and execute daily, weekly, and monthly production schedules to achieve business targets.
- Review and approve Batch Manufacturing Records (BMR), Batch Packing Records (BPR), SOPs, and production documentation.
- Supervise aseptic manufacturing, vial filling, terminal sterilization, lyophilization (freeze drying), and cleanroom operations.
- Coordinate with QA, QC, Engineering, Warehouse,
Maintenance, and Supply Chain for smooth production activities.
- Lead deviation investigations, CAPA implementation, change controls, and root cause analysis.
- Ensure equipment qualification, validation, preventive maintenance, and calibration activities.
- Drive productivity improvement, yield enhancement, cost optimization, and waste reduction initiatives.
- Maintain audit readiness and support regulatory inspections including WHO, MHRA, EU-GMP, and customer audits.
- Ensure adherence to EHS, safety, and housekeeping standards.
- Develop and mentor production teams through training on GMP, SOPs, and aseptic practices.
Desired Candidate Profile
- 1218 years of experience in sterile pharmaceutical manufacturing.
- Minimum 5 years in a Production Manager role handling Ophthalmic and/or Injectable manufacturing.
- Hands-on experience in:
- Ophthalmic Sterile Manufacturing
- Liquid Injectables (SVP/LVP)
- Dry Powder Injectables
- Aseptic Processing
- Lyophilization (Freeze Drying)
- Vial Washing, Sterilization & Filling
- Strong understanding of cGMP, Data Integrity, GDP, and regulatory documentation.
- Experience in handling regulatory audits and customer inspections.
- Excellent leadership, planning, decision-making, and people management skills
Thanks & Regards
HR Department
📌 Production Manager For Ophthalmic/Liquid/DPI Injection For Dehradun (Uttarakhand)
🏢 East African India Overseas
📍 Uttarakhand