Title:  Executive

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.