Analytical Lab Reviewer Executive

6 - 11 years

6 - 11 Lacs

Posted:1 month ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

JOB DESCRIPTION (JD) Designation: Executive/Senior Executive Location: Gurugram Department Name: R&D Quality-CMC QA List of Responsibilities / Job Functions: Review of R&D documents such as stability data, Analytical reports, Method Qualification reports, Method verification reports, Method validation protocols & reports, Working Standard / Impurity Standard profile, analytical data of pilot bio batches and Method transfers protocol & report. Review of Lab event/Deviations/Change control/CAPA and associated investigation reports prior to Technology Transfer. Support and participate in f ailure investigations and resolution of root causes for issues related to systems and products developed within Sun Pharmaceutical Industries Limited R&D sites. Visiting the AD Labs / Areas for verification of GDP & GMP compliance. Audit of Analytical Development department. Ensure the periodic activities as per the quality procedures are performed in a timely manner. Work in partnership with the site cross functions and corporate functions for Audit readiness. Lead the assessment, tracking of remediation and monitoring of identified actions as part of various corporate initiatives. Perform other duties as assigned by Functional Head time to time. Review and approve the periodic activities as per the quality procedures. Support operations team during corporate audit/ external audits Lead the assessment, tracking of remediation and monitoring of identified actions as part of various corporate initiatives. Review of Product development data and specification.

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Sun Pharma logo
Sun Pharma

Pharmaceuticals

Mumbai

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