Quality Assurance 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