Key Responsibilities

1.

Filling

Operations

- Execute aseptic/non-aseptic filling operations as applicable to the product and manufacturing process.

- Operate filling machines, filling lines, pumps, conveyors, and associated equipment.

- Perform line clearance and equipment checks before starting operations.

- Ensure correct product, components, batch number, and packaging materials are used.

- Monitor filling parameters such as fill volume/weight, machine speed, pressure, temperature, and other defined process parameters.

- Perform in-process checks and document results as per approved procedures.

- Maintain aseptic practices and controlled-area behavior where applicable.

- Identify and report deviations, equipment abnormalities, contamination risks, and process discrepancies.

2.

Packing

Operations

- Perform primary and secondary packing activities according to approved batch packaging records.

- Operate labeling, cartoning, coding, serialization, inspection, and packing equipment as applicable.

- Verify packaging components, labels, printed materials, batch details, and expiry dates.

- Perform line clearance before and after each batch.

- Ensure reconciliation of packaging materials and finished product.

- Conduct visual inspection of containers, labels, packs, and finished units.

- Ensure correct segregation and handling of rejected, damaged, or defective materials.

3. GMP & Documentation

- Follow current SOPs, Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), Work Instructions, and GMP requirements.

- Complete manufacturing and packaging documentation accurately and contemporaneously.

- Maintain data integrity in accordance with ALCOA+ principles.

- Report deviations, incidents, non-conformances, and potential quality risks to the appropriate personnel.

- Support investigations, CAPA, change controls, and other quality-system activities when required.

- Ensure proper cleaning, sanitization, and housekeeping of the work area and equipment.

4. Equipment & Maintenance





- Perform equipment operation and routine checks according to SOPs.

- Coordinate with Engineering/Maintenance for equipment breakdowns and abnormalities.

- Assist with equipment cleaning, changeover, setup, and basic troubleshooting.

- Ensure equipment status labels and logbooks are properly maintained.

5. Safety & Compliance

- Follow EHS procedures and use appropriate PPE.

- Handle biological/pharmaceutical materials according to approved safety procedures.

- Maintain proper waste segregation and disposal.

- Immediately report safety incidents, spills, equipment hazards, or unsafe conditions.

Key Performance Areas (KPIs)

- Batch completion within the approved production schedule

- Right-first-time documentation

- Compliance with GMP and SOP requirements

- Filling/packing yield and material reconciliation

- Reduction of rejects and operational errors

- Equipment utilization and downtime

- Deviation and incident compliance

- Line-clearance compliance

- Safety performance

- Audit and inspection readiness

Qualification For Operator:

- ITI / Diploma / B.Sc. or equivalent qualification.

- Experience in pharmaceutical/biopharmaceutical manufacturing is preferred.

For Executive/Officer:

- B.Pharm / M.Pharm / B.Sc. / M.Sc. / B.Tech. or relevant qualification.

- Experience in pharma/biopharma manufacturing, filling, or packing is preferred.

Experience

- Operator: 15 years in pharmaceutical/biopharmaceutical manufacturing or packing.

- Executive/Officer: 2–6 years in pharma/biopharma production, preferably with filling/packing experience.

- Experience with aseptic filling, cleanroom operations, vial/syringe filling, visual inspection, labeling, and secondary packing is advantageous.

Required Skills

- Knowledge of GMP and pharmaceutical manufacturing practices

- Understanding of filling and packing processes

- Knowledge of cleanroom and aseptic practices, where applicable

- Positive documentation and communication skills

- Basic troubleshooting and problem-solving ability

- Attention to detail

- Ability to work in shifts

- Teamwork and cross-functional coordination

- Understanding of data integrity and ALCOA+ principles

📌 Walk-in || Executive , Sr. Executive , Operator , Sr. Operator (Visakhapatnam)
🏢 Hetero Biopharma
📍 Visakhapatnam