Sun Pharmaceuticals is looking for pharma candidates for the following post.
From humble beginnings in 1983, Sun Pharma has grown to become the 5th largest generic pharmaceutical company in the world and No. 1 in India. Our passion for research has enabled us to develop over 2000 products that are sold in more than 100 countries worldwide. Our global presence is supported by over 40 manufacturing facilities spread across six continents and R&D centers across the globe. Innovation is at the core of the Sun. We have nearly 2000 scientists working in six research centers across India, Israel, and the USA who have a passion for innovation and longing to provide better healthcare to humanity at large.
Our multi-cultural workforce, comprising over 30,000 employees from 50 nationalities, is our biggest strength. We recognize our employees passion for growth and empower them to achieve their aspirations. We owe our success to our passionate and skilled workforce. At Sun, one can work with an inspiring, approachable, and visionary leadership. Our open, enabling and trust-based culture will offer you an exciting environment to work and excel in your chosen career.
Title: Executive R&D Quality CMC QA
Department: R&D, QA
Qualification: B.Pharm, M.Pharm
Experience: 2 – 6 years
Salary: Not Disclosed
- 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.