OnsiteClient specificActively hiring Posted today
Associate Production (API)
We are looking for experienced Production Associates with hands-on experience in API manufacturing to support production planning, batch execution, documentation, cGMP compliance, safety, and shop-floor operations.
MysoreFull-time5+ years
About the role
We are looking for experienced Production Associates with hands-on experience in API manufacturing to support production planning, batch execution, documentation, cGMP compliance, safety, and shop-floor operations. The candidate will be responsible for ensuring smooth and compliant production activities while maintaining product quality and safety standards.
What you'll do
- Plan and execute production batches as per targeted production commitments while ensuring compliance with cGMP, safety, quality, and EHS requirements.
- Ensure proper gowning, entry/exit procedures, and PPE usage by all personnel working in the production area.
- Ensure manufacturing activities are carried out strictly as per Batch Manufacturing Records (BMR), Standard Operating Procedures (SOPs), and approved process instructions.
- Monitor production activities and ensure adherence to defined process parameters.
- Maintain good housekeeping and 5S standards across the production shop floor.
- Ensure compliance with cGMP, Safety, Health & Environment (SHE/EHS) requirements throughout production operations.
- Review completed batch records for completeness and accuracy before submitting them to QA for review and final disposition.
- Report deviations, incidents, and abnormalities immediately and support investigations in coordination with QA and other cross-functional teams.
- Ensure all production documentation and online entries are completed accurately, legibly, and on time, with corrections made as per documentation procedures.
- Monitor the manufacturing environment and maintain daily production/log books.
- Coordinate with Engineering/Maintenance teams to ensure preventive maintenance and calibration of equipment, gauges, and instruments are completed as per schedule.
- Ensure required cleaning and sanitization activities are completed as per approved procedures.
- Support QA in investigations related to OOS, deviations, CAPA, incidents, customer complaints, recalls, validations, and other quality-related activities.
- Ensure proper identification and labelling of raw materials, intermediates, and APIs at every stage of the manufacturing process.
- Ensure appropriate segregation and storage of materials under recommended storage conditions to prevent any impact on product quality.
- Conduct regular stock reconciliation of raw materials, intermediates, and finished products as applicable.
- Coordinate with QA, QC, Warehouse, Engineering, EHS, and other cross-functional teams to ensure smooth production operations.
- Perform any other duties or assignments entrusted by the Production Head.
What we're looking for
- B.E., B.Tech, or Diploma in Chemical Engineering, or M.Sc. in Chemistry required.
- 3 to 6 years of experience in API manufacturing or pharmaceutical production.
- Mandatory willingness to work in all three rotational shifts.
- Working knowledge of cGMP, GDP, SOPs, BMR/BPR, EHS, and batch manufacturing documentation.
- Practical skill in deviation handling, CAPA, OOS support, equipment maintenance, and cross-functional collaboration.
- At least 3 years of hands-on API production experience preferred.
- Experience in a regulated API manufacturing environment preferred.
Ready to apply?
Takes ~2 minutes. Resume + a short note is enough.