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.
Key Skills :
Company Profile
--- was established in the year 2000 as a drug development, manufacturing and marketing company. Accepted internationally for its quality medicines, --- aspires to provide eminent and affordable medicines to all
Being a progressive Indian pharmaceutical company we offer a vast range of pharmaceutical, nutraceutical, and ayurvedic medicines in India and overseas as well.
Since the formation of ---, we are endeavouring to be the best in the --- sector by delivering nonpareil pharmaceutical formulations with the help of our Research and Development team.
Years of extensive research have proved to be fruitful as it has helped to serve the well-being of people and nurture the health of citizens.
We have listed the company on National Stock Exchange of India Limited. We have offices in Srilanka, Vietnam, and Nigeria with registered companies.
Apply Now
- Interested candidates are requested to apply for this job.
- Recruiters will evaluate your candidature and will get in touch with you.