Client: Leading Group Pharmaceutical Company having Formulations API Biologics Business
Key Responsibilities
Equipment Maintenance & Operations
- Responsible for operation preventive maintenance and breakdown maintenance of injectable process equipment including:
- Autoclaves Dry Powder Filling Machines Liquid Filling Machines Tunnel Sterilization (Depyrogenation Tunnel) Linear Vial Washing Machines Vial Sealing / Capping Machines etc
- Ensure maximum equipment uptime with minimum downtime.
- Perform equipment installation commissioning qualification support and validation activities.
Preventive & Breakdown Maintenance
- Plan and execute preventive maintenance (PM) schedules as per SOPs.
- Attend and resolve equipment breakdowns promptly.
- Analyze recurring failures and implement corrective and preventive actions (CAPA).
Documentation & Compliance
- Maintain and update equipment logbooks PM records breakdown reports and spare part records.
- Ensure compliance with cGMP GDP and regulatory guidelines (USFDA WHO EU-GMP etc.).
- Support internal and external audits inspections and qualification activities (IQ OQ PQ).
Safety & Quality
- Ensure adherence to safety practices during maintenance activities.
- Follow cleanroom behavior gowning practices and contamination control requirements.
- Participate in deviation investigations and change control activities.
Client: Leading Group Pharmaceutical Company having Formulations API Biologics BusinessKey ResponsibilitiesEquipment Maintenance & OperationsResponsible for operation preventive maintenance and breakdown maintenance of injectable process equipment including:Autoclaves Dry Powder Filling Machines Liq...
Client: Leading Group Pharmaceutical Company having Formulations API Biologics Business
Key Responsibilities
Equipment Maintenance & Operations
- Responsible for operation preventive maintenance and breakdown maintenance of injectable process equipment including:
- Autoclaves Dry Powder Filling Machines Liquid Filling Machines Tunnel Sterilization (Depyrogenation Tunnel) Linear Vial Washing Machines Vial Sealing / Capping Machines etc
- Ensure maximum equipment uptime with minimum downtime.
- Perform equipment installation commissioning qualification support and validation activities.
Preventive & Breakdown Maintenance
- Plan and execute preventive maintenance (PM) schedules as per SOPs.
- Attend and resolve equipment breakdowns promptly.
- Analyze recurring failures and implement corrective and preventive actions (CAPA).
Documentation & Compliance
- Maintain and update equipment logbooks PM records breakdown reports and spare part records.
- Ensure compliance with cGMP GDP and regulatory guidelines (USFDA WHO EU-GMP etc.).
- Support internal and external audits inspections and qualification activities (IQ OQ PQ).
Safety & Quality
- Ensure adherence to safety practices during maintenance activities.
- Follow cleanroom behavior gowning practices and contamination control requirements.
- Participate in deviation investigations and change control activities.
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