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).

<...