Assistant Manager Production

4 weeks ago

Karachi, Sindh, Pakistan Getz Pharma Full time

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.
Seniority level

Associate

Employment type

Full-time

Job function

Production

Industries

Pharmaceutical Manufacturing

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