Working knowledge of cGMPs or other FDA/international regulatory standards. Knowledge of ICH guideline & ISO 9000 standards.
Hands on experience and knowledge of engineering - Mechanical function as plant maintenance, documents and cGMP GEP compliance.
Hands on experience of various MOC Reactors, Centrifuges, Ejectors, RCVD, ANFD, Jet Mill, Dryers, HVAC, Clean rooms, RLAF, LAF etc.
Qualification and validation of equipment HVAC and facility
Revenue Budget preparation and compliance
Energy conservation and continual improvement in the system
Liasoning with statutory body as GIDC, Factory Inspector, FDA
Training to subordinate to enhance skill and competency
Safety compliance, Energy conservation and continual improvement in the system
Liasoning with statutory body as GIDC, Factory Inspector, FDA
Job Types: Full-time, Permanent
Pay: ₹20,000.00 - ₹35,000.00 per month
Benefits:
Food provided
Health insurance
Leave encashment
Paid sick time
Provident Fund
Work Location: In person
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