+ 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+ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.