Found Description
Job Description – Injectable Manufacturing (Aseptic Operations)
- Operate and monitor aseptic equipment (vial/syringe filling lines, isolators, depyrogenation tunnel, autoclaves, lyophilizers, formulation vessels, sealing machines).
- Ensure cGMP-compliant production operations with accurate real-time documentation.
- Prepare and review SOPs, BMRs, and perform SAP entries.
- Support equipment qualification/validation and routine production activities.
- Ensure area and equipment cleaning as per approved SOPs.
- Monitor BMS parameters (temperature, differential pressure, humidity) and maintain records.
- Handle QMS elements: deviations, change controls, and CAPA.
- Prepare risk assessments, protocols, study reports, and technical documents.
- Review production records for compliance and completeness.
- Train personnel on cGMP, SOPs, BMRs, and Good Documentation Practices (GDP).
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