Quality Assurance Lead

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.