Executive, sr. Executive , Operator

Job Description Filling Department

Job Title: Executive / Senior Executive – Filling
Department: Production – Filling
Industry: Pharmaceutical / Biopharmaceutical
Reporting To: Production Manager / Head – Production

Job Purpose

Responsible for execution and supervision of aseptic/sterile filling operations in compliance with GMP, SOPs, safety requirements, and approved manufacturing procedures, while maintaining product quality and batch integrity.

Key Responsibilities

• Execute and supervise filling operations for sterile/biopharmaceutical products.
• Operate and monitor filling machines, equipment, and associated systems.
• Perform line clearance and area/equipment readiness checks before batch initiation.
• Ensure compliance with cGMP, SOPs, BMR/BPR, and data-integrity requirements.
• Perform dispensing/charging of components as per approved batch documentation, where applicable.
• Monitor critical process parameters during filling operations.
• Perform in-process checks such as fill volume, container closure integrity-related checks, and visual inspection requirements as applicable.
• Ensure proper handling of sterile components, containers, closures, and filled units.
• Maintain aseptic practices and appropriate gowning/environmental-control requirements.
• Record production activities accurately and contemporaneously in batch records and logbooks.
• Report deviations, incidents, equipment abnormalities, and process-related issues to the appropriate functions.
• Coordinate with QA, QC, Engineering, Warehouse, and Maintenance for smooth batch execution.
• Support investigations, CAPA, change controls, and process improvement activities.
• Ensure proper cleaning, sanitization, and housekeeping of the filling area.
• Follow EHS requirements and maintain safe working practices.
• Participate in training, qualification, media fills, aseptic process simulations, and other applicable validation activities.

Qualification

• B.Pharm / M.Pharm
• B.Sc./M.Sc. in Biotechnology, Microbiology, Chemistry, or related discipline
• Diploma/B.Tech may be considered depending on the role and organization.

Experience

• Typically 2–8 years of relevant experience in pharmaceutical/biopharmaceutical manufacturing.
• Experience in sterile/aseptic filling is preferred for sterile manufacturing roles.

Key Skills

• GMP/cGMP knowledge
• Aseptic processing practices
• Filling-machine operation
• Batch documentation
• Deviation and CAPA awareness
• Good documentation practices (GDP)
• Data integrity
• Troubleshooting and problem-solving
• Cross-functional coordination

2. Job Description – Packing Department

Job Title: Executive / Senior Executive – Packing
Department: Production – Packing
Industry: Pharmaceutical / Biopharmaceutical
Reporting To: Production Manager / Head – Production

Job Purpose

Responsible for execution and supervision of primary/secondary packing operations while ensuring compliance with GMP, approved packing instructions, quality requirements, and safety procedures.

Key Responsibilities

• Execute and supervise packing operations according to approved packing instructions.
• Operate and monitor packing equipment and machines.
• Perform line clearance before commencement and after completion of packing activities.
• Verify packing materials against approved specifications and batch documentation.
• Ensure correct product, batch number, artwork, labels, cartons, leaflets, and other packaging components are used.
• Perform in-process checks during packing operations.
• Maintain reconciliation of printed and packaging materials.
• Ensure proper segregation and control of rejected, damaged, excess, and unused materials.
• Complete BPR/BMR, packing records, logbooks, and other documentation accurately.
• Monitor machine performance and coordinate with Engineering/Maintenance for breakdowns.
• Report deviations, incidents, mix-ups, and abnormalities immediately.
• Coordinate with QA, QC, Warehouse, and Production teams.
• Ensure compliance with GMP, SOPs, GDP, and data-integrity requirements.
• Maintain cleanliness and housekeeping of packing areas.
• Support investigations, CAPA, change controls, validation/qualification activities, and continuous improvement initiatives.