Senior Executive - Biotechnology DQA

Senior Executive – Biotechnology (DQA) 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++. Compilation and review of process and analytical documents for regulatory filing and CMC review.