Deputy Manager
4 weeks ago
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.
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