Officer - Regulatory Affairs

22 hours ago

Surat, Gujarat, India SDP HR Solution Full-time ₹3,00,000 - ₹5,00,000 Contract

Free with email or Google

Save this job and keep your search organized

Create a free account to save jobs, create alerts and return to this listing from your dashboard.

Free with email or Google

By continuing, you agree to our Terms & Privacy Policy.

Require engineer experience of break down & trouble shooting, routine repairs and maintenance activities of all Formulation equipment's.
Required experience of vial & ampoule line equipment's of injectable facility, handling maintenance of machines like Vial washing, Vial Filling & sealing machine, Rotary washing, Filling & Sealing, Dry Powder Line, inspection & Packing machines autoclave,
Perform breakdown maintenance, corrective maintenance, electrical maintenance, mechanical maintenance, and preventive maintenance on equipment such as injectables, sterile machines, etc.
Conduct routine checks to identify potential issues before they become major problems.
Troubleshoot and resolve technical issues related to plant operations.
Collaborate with other teams to optimize production processes and improve overall efficiency.
Ensure compliance with safety protocols and quality standards.
Documentation knowledge like DQ, IQ, OQ.
Strong understanding of breakdown analysis, breakdown maintenance, engine design principles, and predictive/preventative maintenance techniques.
Familiarity with GMP regulations (USFDA), ISO standards (ISO 9001), ICH guidelines (ICH Q3D), BPR review process.