Executive - Manufacturing (Injectable/Parenteral)

Role

Location:

Department:

Key Responsibilities:

Production Operations:

Plan, organize, and execute the manufacturing batches of small volume injectable products.

Operate / supervise key equipment: vial/ampoule washing, sterilization (autoclave, filtration), filling, sealing, capping, tunnel sterilizer, lyophilizer (if applicable) etc.

Ensure line readiness, material dispensing, line clearance before/after operations.

Aseptic Process & Sterility Assurance:

Maintain cleanroom operations, gowning, environmental monitoring, microbial monitoring.

Ensure correct operation of aseptic filling / sterile filtration / sterilization steps.

Carry out / support media fill / process qualification / filter integrity tests.

Quality & Compliance:

Ensure all manufacturing activities comply with internal SOPs, company policies, and regulatory requirements (e.g. Schedule M / WHO GMP / USFDA etc.).

Manage batch records (BMR), documentation, deviations, change control, CAPA and rectify nonconformities.

Support audits and inspections, both internal and external / regulatory.

Validation / Cleaning / Utilities:

Oversee validation / qualification (IQ, OQ, PQ) for processes and equipment used in small volume injectable.

Maintain utilities required Water for Injection (WFI), clean steam, compressed air, etc.

Monitor and ensure proper cleaning / sterilization of equipment, proper functioning of CIP / SIP systems.

Process Optimization & Efficiency:

Monitor yields, wastage, downtime; identify improvement opportunities.

Work on continuous improvement initiatives to optimize processes, reduce rejects, reduce cost, improve throughput.

Coordination & Documentation:

Coordinate with QA, QC, Engineering, Supply Chain, Validation to ensure smooth flow of materials, equipment, documentation.

Ensure timely preparation, review, and update of SOPs, BMRs, work instructions.

Safety, Environmental & Regulatory Oversight:

Enforce safety, hygiene, EHS practices in sterile environment.

Ensure compliance with regulatory norms; keep updated on regulatory changes affecting SVPs.

Team Management:

Supervise operators, technicians; provide training specifically for aseptic / sterile techniques.

Ensure staff adhere to gowning, cleanroom behavior and protocol.

Required Qualifications & Skills:

• Bachelor’s degree in Pharmacy/ M.Sc.

• Experience

  : 6+ years in small volume injectable / sterile parenteral manufacturing.
• Solid knowledge of aseptic techniques, sterilization methods, cleanroom behavior, environmental monitoring.
• Understanding of regulatory and GMP standards for sterile products; familiar with guidelines specific to SVIs.
• Handson experience with equipment: vial/ampoule washing, filling/sealing machines, autoclaves, filters, tunnel sterilization etc.
• Strong documentation skills; adept at deviation / CAPA / change control processes.
• Good analytical skills, attention to detail; ability to track and interpret batch performance metrics.
• Good communication skills; ability to work with crossfunctional teams.
• Ability to follow and enforce safety, hygiene, cleanroom discipline.