Founded in 1983, Sun Pharma IS NOW THE 5th Largest Manufacturer of Generics in World, and No1 Company in India. Sun Pharma has above 40 Manufacturing Facilities in compliance with Regulatory Bodies like USFDA, MHRA, TGA, etc.
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Position: Executive R&D Quality CMC QA
Location: Vadodara, Gujarat
Job Description:
- To review QMS documents for cGxP compliance and centralized QA oversight for Analytical GMP Laboratories. To approve QMS documents in the absence of Group leader
- To perform the gap assessment of the Global document & track the implementation of GxP related Global documents (GQS & GSOP).
- To prepare the trend of QMS documents for continuous improvement.
- To provide support for computerized systems to be implemented into R&D and to ensure the compliance of the same. Review of computer system validation documents.
- To assist in developing procedures/quality systems and assure compliance of the same by identifying GAP through document review and Audits.
- Monitoring, Review, and managing In-vitro BABE study and ensuring compliance as per regulatory requirements and established procedure.
- Review / Prepare SOPs for the compliance of the cGMP requirements and monitoring its implementation.
- To assess the compliance level of all the GxP departments through Self Inspection / Internal Audit program. To support all-time readiness for successful regulatory inspection at R&D.
- To review and approve external sample analysis reports.
- To perform the responsibilities of LTC/DTC for LMS activities & Coordinator for EDMS.
- To execute document issuance activity as per cGMP principles and SOPs.
Qualification: B.Pharma, MS/M.Sc/M.Pharma
Experience: 2-6 Years
Salary: Negotiable
Contact Details:
Mr. Vignesh Iyer
vignesh.iyer@sunpharma.com
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