Executive

2 days ago


Tandalja Vadodara Gujarat, India Sun Pharmaceutical Industries Ltd Full time

**Title**:Executive**:

- Date: Jan 22, 2025
- Location: Tandalja - R&D
- Company: Sun Pharmaceutical Industries Ltd
- Officiate in Quality Assurance functions of early stage development of biologics, biosimilars.
- Responsible for lifecycle management of development 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 latest quality and regulatory requirements
- Development, Implementation and continual improvement of 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++


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