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Pharvinex Group

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Executive-Quality Assurance

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Summary

Pharmaceutical Quality Assurance Executive at Pharvinex Group in Kota, India: drafts QA SOPs, ensures cGMP compliance, reviews batch manufacturing records (BMR), manages deviations/CAPA and non-conformances, and supports EHS and data-integrity activities. Requires a B.Pharma or M.Sc. in Chemistry background.

Education – B. Pharma / M.Sc. (Chemistry)

Key Roles and Responsibilities:

· Responsible to draft quality assurance procedures, SOPs.

· Ensure effective implementation of system and procedure as per cGMP.

· Review BMR for their correctness and retention until destruction.

· Issuance of BMR, Cleaning checklists, Logbook and Labels as per requirement.

· Online observation of process deviation and effective implementation of CAPA.

· Training of new employees, system practices and procedures to develop competency.

· Review of executed batch manufacturing, packaging documents & other quality documents.

· Handling of non-conformance.

· To ensure the EHS (Environment, Health and Safety) related activities to be completed on time and to support EHS activities as per requirement.

· To report near miss and incidences as observed as per EHS requirement.

· To ensure data integrity compliances at site and while performing activities.



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