List of Responsibilities I Job Functions: Timely validation of analytical methods of the drug products and API (intermediates and key starting material) for the drug products I drug substances to be filed globally. This role necessitates understanding of cGMP requirements and good technical knowledge to validate analytical methods and establish their suitability for the intended use. Documentation of data as per laid down procedures during execution of validation experiments Interaction with Internal compliance group/R&D quality-CQA to answer their queries during review of validation documents. . Transfer of analytical methods at different plant locations before exhibit batches. Ensuring cleanliness in GMP area at all times in terms of proper labeling at all designated places and arrangement of chemicals. The role requires continuous up gradation in terms of regulatory and GMP requirements pertaining to method validations and attending SOP / Compliance related trainings. Any other responsibilities assigned from time to time orally or in writing.
