Officer - Regulatory Affairs

Officer - Regulatory Affairs

Job Description:

- 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.

▶️ Officer - Regulatory Affairs
🖊️ SDP HR Solution
📍 Surat