Position : Executive – Engineering QMS
Qualification : BE Mechanical/Electrical/Instrumentation or B pharma …preferably BE
Experience : 6-7 years experience in handling engineering department GMP documentation activities and supporting engineering function as SME in QMS documentation
Responsibilities :
- Implementation of quality assurance standards, processes, controls and cGMP in warehouse.
- Preparation of SOPs and ensure effective implementation.
- should be well versed with deviation management SOP
- Should be well versed with change control and CAPA management related to engineering department
- Should be familiar with documentation like DQ, IQ, OQ and PQ.
- To ensure that training for SOP’s, GDP, cGMP and On the Job training are imparted to staff as per
Schedule
- Routine Requalification & Validation of HVAC systems, compressed gases and equipment.
- Preparation of all planners like Preventive maintenance, calibration, requalification etc in engineering function
- To ensure compliance to Regulatory, ISO and WHO GSDP requirements.
- should coordinate for the drawing preparation and approvals.
- should have experience on working with QMS software like trackwise