Assistant Manager Production

Job Summary

The incumbent will be responsible for supervising and managing routine aseptic manufacturing operations (e.g., vial/ampoule filling, compounding, filtration, sealing, lyophilization), ensuring compliance with approved BMRs, SOPs and applicable regulatory guidelines, and monitoring cleanroom operations (Grade A/B/C/D) to maintain aseptic conditions.

Key Responsibilities

• Receiving of API and Packaging materials from warehouse.
• Supervise the compounding, filtration, sterilization, washing, filling and sealing operations of sterile products as per GMP standards.
• Supervise optical inspection area, labeling and packaging operation
• Prepare SOPs as per guidelines
• Ensure 100% compliance of monthly production schedule.
• Ensure timely issuance and submission of BMRs & BPRs for each batch.
• Supervise the execution of Media Fill Trials.
• Ensure good documentation practices are followed & logbooks, BMRs and BPRs are timely updated.
• Make all entries in SAP after completions of manufacturing & packing steps.
• Maintain OEE of equipment
• Manage supply plan as per demand
• Manage resource for smooth operation and maintain machine and labor utilization
• Coordinate with R&D and validation for new developments and qualification.

Qualifications, Knowledge, and Skills

• A professional degree in Pharmacy (Pharm-D).
• 5+ years of experience in sterile manufacturing.
• Hands-on experience with Good Manufacturing Practices (GMP) specific to sterile manufacturing.
• Familiarity with regulatory guidelines such as FDA, EMA, WHO, and local drug authorities.
• Expertise in Batch Manufacturing Records (BMRs), SOPs, deviation handling, and CAPA.
• Knowledge of equipment sterilization (autoclave, dry heat), SIP/CIP systems, and sterilization validation.
• Good communication and presentation skills.
• Good understanding of SAP.