Execute daily production activities in the injectable (sterile/aseptic) manufacturing area as per batch manufacturing records (BMRs) and SOPs. ? Monitor and ensure adherence to cGMP practices, cleanroom discipline, and aseptic techniques during manufacturing processes. ? Operate and supervise machines like autoclaves, vial washing, filling, sealing, and lyophilization (if applicable). ? Coordinate with QA/QC, engineering, and warehouse teams for smooth batch execution. ? Maintain records and documentation - BMR, logbooks, calibration, cleaning records, and other regulatory documentation. ? Perform line clearance and ensure availability of materials, equipment, and utilities before batch start-up. ? Participate in deviation handling, change controls, CAPA, and other quality-related investigations. ? Ensure timely reporting of production data and support audits (internal and external). ? Train and guide operators and workers on SOPs, GMP, safety, and hygiene standards. Required Skills and Competencies: ? Sound understanding of sterile/aseptic injectable manufacturing processes. ? Knowledge of GMP, GDP, cleanroom classifications, and regulatory compliance (WHO GMP / EU-GMP / MHRA / USFDA). ? Ability to operate and troubleshoot injectable equipment. ? Good documentation and communication skills. ? Attention to detail, discipline, and teamwork attitude. Preferred Experience: ? Prior experience in a regulated injectable manufacturing facility (SVP or LVP).
Job Type: Full-time
Pay: ?25,000.00 - ?30,000.00 per month
Schedule:
Day shift
Work Location: In person
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