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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