Sr Quality Assurance Associate

6 - 7 years

3.0 - 7.0 Lacs P.A.

Pune

Posted:2 months ago| Platform: Naukri logo

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Skills Required

Finished productsMethod validationExternal auditAnalyticalQMSAssociate Quality Assurancedata integrityAnalytical instrumentsRaw materialAnalytical method validation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Description Summary Responsible for Analytical data review of Stability, Finish Product, Investigations (OOS/OOT/Deviations) . Handling of Technical agreement, QMS Trending, Self inspections. Job Description Knowledge about ICH, USFDA guidelines Data integrity principles. Knowledge on review of Qualification calibration of Analytical instruments. Technical knowledge on data review for finished product/stability/Raw material samples and analytical method validation/verification Having knowledge of quality management system (Change control, CAPA, Incidents, OOS, OOT) Experience to handle the internal external audits. Preparation and Review of SOP, laboratory documents like method validation/ verification protocols reports, SOP s, Standard Test Procedure Specification. Maintain good documentation practices. Participate in Investigation of incident, deviation, OOS, and OOT during analysis. Education Experience M.Sc. Chemistry/M. Pharm with 6-7 years of related experience.

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