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SUN PHARMA
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Executive/Senior Executive

Executive/Senior Executive

SUN PHARMA

3 - 7 years

0 Lacs

haryana

Posted:21 hours ago| Platform: Shine logo

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Skills Required

rd deviations change control capa technology transfer audit analytical development quality procedures corporate audit qualitycmc qa analytical reports method qualification reports method verification reports method validation protocols working standard impurity standard profile analytical data method transfers protocol lab event failure investigations gdp gmp compliance external audits product development data specification

Work Mode

On-site

Job Type

Full Time

Job Description

As an Executive/Senior Executive in the R&D Quality-CMC QA department at Gurugram location, your role involves the following responsibilities: - Review various R&D documents including 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 lab events, deviations, change controls, CAPA, and associated investigation reports before Technology Transfer. - Support and actively participate in failure investigations, identifying root causes for issues related to systems and products developed within Sun Pharmaceutical Industries Limited R&D sites. - Conduct visits to AD Labs / Areas to verify compliance with GDP & GMP standards. - Conduct audits of the Analytical Development department. - Ensure timely completion of periodic activities as per quality procedures. - Collaborate with site cross functions and corporate functions to ensure Audit readiness. - Lead the assessment, tracking, and monitoring of remediation actions as part of various corporate initiatives. - Perform any other duties assigned by the Functional Head. - Review and approve periodic activities in line with quality procedures. - Support the operations team during corporate audit and external audits. - Review product development data and specifications. (Note: No additional details about the company were provided in the job description),

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Executive/Senior Executive