Walk-in | Executive , Sr. Executive , Operator , Sr. Operator

Hetero Biopharma Ltd; Visakhapatnam; On-site; INR 500,000 - 900,000; Full time

Job summary

Hetero Biopharma Ltd in Visakhapatnam, India, is seeking experienced operators and executives for filling and packing roles within a GMP-compliant manufacturing environment. The position requires adherence to SOPs, BMR/BPR documentation, and ALCOA+ data integrity.

Responsibilities include operating filling and packing lines, ensuring quality and traceability, and participating in safety protocols and shift operations. Prior experience in pharma production is preferred.

Qualifications

• Experience in pharmaceutical/biopharmaceutical manufacturing is preferred.
• Experience in pharma/biopharma production, filling or packing is preferred.
• Knowledge of GMP and pharmaceutical manufacturing practices.
• Understanding of data integrity and ALCOA+ principles.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

Job description

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
• Good 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