Deputy Manager / Manager - CQA

Experience -

Qualification -

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.