Cadchem Laboratories Ltd.
API Pharmaceutical Manufacturing Plant
Engineering HVAC QMS Documentation
Qualification : B.Tech / Diploma Mechanical Engineering
Experience : 4-6 years in API Pharma
Key Responsibilities:
1. HVAC System Management:
- Operation, maintenance, and monitoring of HVAC systems in API manufacturing areas.
- Ensure compliance with cGMP requirements for temperature, humidity, differential pressure, and air changes.
- Periodic monitoring of cleanroom parameters and troubleshooting deviations.
- Handling of AHU systems, chillers, ducting, filters (HEPA), and ventilation systems.
- Execution of HVAC validation (IQ, OQ, PQ) and requalification activities.
- Preparation and review of HVAC SOPs, protocols, and reports.
2. QMS Documentation:
- Preparation, review, and control of SOPs, protocols, reports, logbooks, and formats.
- Handling of Change Control, Deviation, and CAPA documentation.
- Ensuring documentation compliance with regulatory guidelines (USFDA, MHRA, WHO, etc.).
- Participation in internal and external audits and compliance readiness.
3. CAPA & Investigation:
- Perform root cause analysis using tools like Fishbone, 5 Why, etc.
- Preparation and closure of CAPA within timelines.
- Investigation of engineering-related deviations and non-conformances.
- Coordination with cross-functional teams for effective implementation.
4. Calibration Activities:
- Planning and execution of calibration for instruments (Temperature, Pressure, RH sensors, gauges, transmitters).
- Preparation of calibration schedules and records.
- Vendor coordination for external calibration services.
- Ensuring traceability to national/international standards.
Pay: ₹30,000.00 - ₹40,000.00 per month
Work Location: In person
