Experience: 4 – 6 Years
Education: B.Sc. (Life Sciences / Chemistry / Biotechnology or related discipline)
Role Summary
We are looking for a dedicated Junior Associate – Production (Downstream) to support manufacturing operations in line with Good Manufacturing Practices (GMP) and EHS compliance. The role involves real-time documentation, execution of protocols, equipment handling, and ensuring high-quality, compliant production processes. This position requires strong attention to detail, hands-on experience in downstream operations, and a proactive approach to maintaining regulatory standards.
Key Responsibilities
- Monitor compliance with Good Manufacturing Practices (GMP) in production areas.
- Ensure strict adherence to production instructions and operational procedures.
- Perform real-time data entry in BMRs, CKL, LS, ECC, and related production documents.
- Execute equipment qualification and validation protocols accurately.
- Carry out and document all activities in accordance with cGMP standards.
- Coordinate with maintenance for equipment calibration and upkeep.
- Comply with all EHS (Environment, Health & Safety) policies and procedures.
- Ensure On-Time-In-Full (OTIF) execution of all downstream (Buffer Preparation) activities.
- Report, evaluate, and document all production deviations; ensure critical deviations are thoroughly investigated.
- Support the training and development of downstream personnel, ensuring continuous compliance.
- Prepare, revise, and maintain Batch Manufacturing Records, SOPs, EOPs, Checklists, and Log Sheets.
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Act as the data owner for process equipment, ensuring accurate and reliable documentation.
Educational Qualifications & Experience
- Education: B.Sc. in Life Sciences / Biotechnology / Chemistry (or related field).
- Experience: 4 – 6 years in production operations, preferably in a regulated (cGMP) environment.