02 Oct
|
Hetero Biopharma
|
Visakhapatnam
02 Oct
Hetero Biopharma
Visakhapatnam
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 secure 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.
📌 Executive, sr. Executive , Operator (Visakhapatnam)
🏢 Hetero Biopharma
📍 Visakhapatnam