Founded in 1983, Sun Pharma is now the 5th largest Generic Pharmaceutical Company in the world and No. 1 in India. With the Portfolio of over 2000 products that are sold in more than 100 countries worldwide. The global presence of Sun Pharma 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. Sun Pharma has nearly 2000 scientists working in six research centers across India, Israel, and USA who have a passion for innovation and longing to provide better healthcare to humanity at large.
Sun Pharma is offering an Opportunity for Competent Professionals to Join its team of QC R&D.
Position: Biotechnical Research Associate/Scientist
- Officiate in Quality Assurance functions of early-stage development of biologics, biosimilar, and vaccines
- Responsible for the lifecycle management of developing products with respect to knowledge management and lifecycle management as per ICH. Management of process changes in early phase development
- Review of clone development and cell banking documentation and ensuring regulatory compliance in plans and reports
- Review of product development documents such as process development reports, process descriptions, process control strategy documents, etc.
- Review of analytical developments such as method development reports, method qualification/validation protocols and reports and ensure compliance as per the latest quality and regulatory requirements
- Development, Implementation, and continual improvement of the Quality Management System at R&D through SOPs, Manuals, training, and audits and ensuring alignment with corporate QA and site QA.
- Verification of Laboratory data and its integrity, ensuring good documentation practices and data reporting as per ALCOA++
- Compilation and review of the process and analytical documents for regulatory filing and CMC review
- Control of documents, issuance of working copies, verification of raw data, and archival of soft and hard copy documents based on ALCOA+ principals.
- Key responsibilities would be to ensure “Adult readiness at all times” and defending QMS and the ability to respond to audit queries from Regulatory Agencies, clients, and business partners.
Qualification: B.Tech/B.E – Bio Chemistry/BioTech, M.Pharma, MS/M.Sc
Experience: 10 – 15 Yrs
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