Key Responsibilities
- Manage end-to-end OSD manufacturing operations including:
- Granulation
- Compression
- Coating
- Capsule Filling
- Blister/Bottle Packing
- Prepare and execute daily/weekly/monthly production plans.
- Ensure compliance with cGMP, WHO-GMP, Schedule M, SOPs, and regulatory requirements.
- Monitor productivity, machine utilization, and batch completion as per schedule.
- Coordinate with QA, QC, Warehouse, Engineering, and Planning departments.
- Review Batch Manufacturing Records (BMR), logbooks, and production documentation.
- Investigate deviations, implement CAPA, and ensure timely closure.
- Lead regulatory audits (USFDA, MHRA, EU-GMP, WHO, etc.) and customer audits.
- Control manpower, training, discipline, and shift management.
- Ensure equipment qualification, cleaning, preventive maintenance, and calibration coordination.
- Drive continuous improvement, cost reduction, and waste minimization initiatives.
- Maintain EHS (Environment, Health & Safety) standards across production areas.
Qualification
- B.Pharm / M.Pharm / B.Sc / M.Sc (Pharmaceutical or relevant discipline)
Experience
- 10–15 years in OSD pharmaceutical manufacturing.
- Minimum 5-7 years in a managerial role.
- Strong exposure to tablets and capsules manufacturing, regulatory compliance, and audit handling.
Required Skills
- Production Planning & Control
- cGMP, GDP & SOP Compliance
- Team Leadership & Manpower Management
- Deviation, CAPA & Change Control
- Root Cause Analysis
- Lean Manufacturing / Productivity Improvement
- Excellent communication and decision-making skills
Pay: ₹1,500,000.00 - ₹1,800,000.00 per year
Benefits:
- Food provided
- Health insurance
- Life insurance
- Paid sick time
- Paid time off
- Provident Fund
Work Location: In person
