Deputy Manager

Experience - 10 to 16 years Qualification - M.Sc. (Chemistry) Responsibilities - Review change controls deviations and other quality system investigations across locations and send them for approval. - Review vendor qualification documents including vendor questionnaires and interact with the related departments to ensure documentation is completed as per the requirements. - Execute internal audits at all locations annually. - Prepare and issue CQA guidelines to all sites and maintain all CQA documentation in line with good documentation practices. - Review corporate SOP's and provide recommendations for improvement. - Review process validations protocol and reports, stability protocols, MPR's of manufacturing location and corporate departments and equipment qualification documents and provide recommendation for improvements. - Perform vendor audits as per annual audit planner or as and when required. - Perform elemental impurity risk assessments for Unichem Locations. - Approve change controls, deviations, validation protocol / reports and other quality system investigations etc. provided by locations in absence of Head CQA and DGM CQA - Perform any other related activity as instructed by Head CQA. Desired Skills - Experience in QA related activities in a reputed pharmaceutical organization. - Should have excellent knowledge of CQA activities, vendor qualification internal audits, and external audits. - Exposure to regulatory audits like USFDA,MHRA,EU and other related inspection is must. - Good interpersonal, communication and problem-solving skills. - Should be assertive, proactive and self-driven. - Ability to work in a fast-paced, demanding, timeline-driven environment.