HomeProductionQuality Assurance Executive | Piramal Enterprises | Ennore, Chennai, TN

Quality Assurance Executive | Piramal Enterprises | Ennore, Chennai, TN


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Position: Executive Quality Assurance

Location: Ernavoor, Chennai, Tamil Nadu

Job Description:

  • Strict adherence to GMP, GDP & DI norms and safety rules of the factory.

  • Initiation of change control for QA and review of change control from other functions.

  • Review of QMS documents related to API Services products such as change control, deviation, OOS/OOT, Investigations and followed by tracking and monitoring of CAPA till closure.

  • Review of OOS/OOT investigation from Quality control and other functions.

  • Initiation of deviation for QA and review of deviation from other functions.

  • Review of the investigation report arises from failure/deviation investigation.

  • Review of Product Development reports (PDR) and R&D use test reports.

  • Review of Masterbatch manufacturing, packing records, and laboratory control records.

  • Review of executed batch manufacturing, packing, and laboratory control records of critical process steps and ensuring critical deviations are investigated and resolved before the release of the API/Intermediate for distribution.

  • Batch release of API/Intermediate for distribution.

  • Review of equipment cleaning SOP executed cleaning batch records, cleaning validation, and line clearance for products.

  • Preparation of QA related SOPs and review of draft SOPs from other functions.

  • Initiation of stability notification for Intermediate/API wherever applicable.

  • Preparation of customer questionnaires and review of agreements.

  • Issuance of quality system documents and forms for operational use.

  • Preparation of Annual Product quality review (APR) and trend analysis on need basis.

  • Preparation and review of process/analytical related validation protocols and reports.

  • Issuance & receipt of all controlled documents as per the document control procedure.

  • Review of equipment/system related qualification document.

  • Responsible for the management of ‘Ensure’ for uploading of QA SOPs and distribution of SOPs & STPs after approval and effect of the document.

  • Responsible for audit readiness and support for timely retrieval of the document during the audit process.

  • Shop floor vigilance as and when required.

Qualification: B.Pharma/M.Pharma

Experience: Freshers/Experienced

Salary: Negotiable

Contact Details:


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