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 protected]

Job Snapshot

Updated Date

08-08-2026

Job ID

JOB10519

Division

MORAIYA

Location

Manufacturing-formulation-moraiya, Ahmedabad, Gujarat, India ..+ 1

Experience

5 - 12 Years

Employee Type

C-C8-Confirmed-HO Executive

📌 QMS Engineer for OSD Plant (Ahmedabad)
🏢 Zydus Lifesciences
📍 Ahmedabad