27 Sep
|
Intas
|
Ahmedabad
Role & responsibilities: -
- Equipment Maintenance: Manage preventive, predictive, and breakdown maintenance for core OSD machinery including Granulation, High-Speed Compression, Coating, Capsule Filling, and Blister Packaging lines to minimize downtime.
- Utility Management: Oversee the continuous operation and monitoring of plant utilities, specifically HVAC systems, Purified Water (PW) plants, compressed air, and chillers, ensuring cleanroom environments meet strict regulatory compliance.
- Regulatory Compliance: Ensure all maintenance, operations, and facilities strictly adhere to global pharmaceutical standards, including USFDA, MHRA, and WHO-GMP guidelines.
- QMS Documentation: Lead engineering Quality Management System (QMS) processes, including managing Change Controls, Deviations, Investigations, and implementing CAPAs with zero data integrity lapses.
- Qualification & Validation: Execute and document Installation Qualification (IQ) and Operational Qualification (OQ) for new and modified process equipment and utility systems.
- Calibration Tracking: Manage the calibration master tracker,
ensuring all critical instrumentation and process control devices are calibrated timely and accurately.
- Audit Readiness: Serve as the subject matter expert during internal and external regulatory audits to defend maintenance logs, engineering history, and standard operating procedures (SOPs).
- SAP & Automation: Leverage SAP (PM Module) for managing work orders, tracking spare parts inventory, and documenting equipment history sheets.
- EHS Compliance: Enforce Good Engineering Practices (GEP) alongside strict Workplace, Health, and Safety (EHS) guidelines across the shop floor.
- Team & Vendor Leadership: Supervise, train, and guide shift technicians and junior engineers while coordinating effectively with external OEM vendors for specialized technical support.
Preferred Candidate Profile: -
- Required Experience: - 4 to 10 Years
- Required Educational Qualification: - B.E. / B.Tech./M.E./ M.Tech.
Regards, Human Resources Team,
Intas Pharmaceuticals SEZ Plant
📌 Job Opportunity For Officer / Executive - Engineering (OSD) (Ahmedabad)
🏢 Intas
📍 Ahmedabad