QMS Engineer for OSD Plant

J ob 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. 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 hidden]>