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:
1.Implementation of quality assurance standards, processes, controls and cGMP in warehouse.
2.Preparation of SOPs and ensure effective implementation.
3.Should be well versed with deviation management SOP.
4.Should be well versed with change control and CAPA management related to engineering department.
5.Should be familiar with documentation like DQ, IQ, OQ and PQ.
6.To ensure that training for SOP's, GDP, cGMP and On the Job training are imparted to staff as per schedule.
7.Routine Requalification & Validation of HVAC systems, compressed gases and equipment.
8.Preparation of all planners like Preventive maintenance, calibration, requalification etc in engineering function.
9.To ensure compliance to Regulatory, ISO and WHO GSDP requirements.
10.Should coordinate for the drawing preparation and approvals.
11.Should have experience on working with QMS software like Trackwise.
Location: On-site – Mumbai, MH
Scheduled Weekly Hours: 48
