Job Responsibilities – QMS Engineer (Engineering Department, OSD Plant)
1. Quality Management System (QMS) Activities
- Implement and maintain QMS processes in line with GMP, WHO, USFDA, and EU guidelines.
- Manage SOPs, deviations, change controls, and CAPA related to engineering and maintenance.
- Ensure compliance of engineering operations with regulatory and audit requirements.
- Conduct root cause analysis for equipment-related deviations and establish preventive measures.
- Support internal and external audits with engineering documentation and QMS records.
2. Plant Maintenance & Utilities
- Oversee preventive and predictive maintenance of OSD manufacturing equipment (granulators, compressors, coating machines).
- Ensure proper functioning and compliance of HVAC, purified water, WFI, compressed air, and clean utilities.
- Maintain calibration schedules for instruments and ensure accuracy in production and testing.
- Coordinate with production teams to minimize downtime and ensure smooth operations.
3. Validation & Compliance
- Execute equipment qualification (DQ, IQ, OQ, PQ) and utility validation protocols.
- Ensure engineering systems meet regulatory and GMP standards.
Maintain validation and calibration documentation for audits and inspections.
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Education: B.E./B.Tech in Mechanical, Electrical or Instrumentation
Experience: 3–8 years in pharmaceutical engineering, preferably OSD manufacturing.
Interested candidates share cv on [email protected]
