Senior Executive

sun pharma industries

7 - 10 years

10 - 15 Lacs

gurugram

Posted:-1 days ago| Platform:

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Skills Required

product quality senior executive r&d manager quality assurance project management analytical pharma manager quality control gmp stp auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Review of R&D documents such as stability data, Analytical reports, Method verification reports,
Method validation protocols & reports, analytical data of pilot bio batches/DQ batches and Product development data for its adequacy, accuracy and completeness as per regulatory and business requirement in order to achieve robust method development and to decrease method failure at site.
Review of QMS documents like Lab Events/Deviations/Change control/CAPA and associated investigation reports prior to Technology Transfer.
Support and participate in failure investigations and resolution of root causes for issues related to systems and products developed within Sun Pharmaceutical Industries Limited R&D sites.
Review facility and equipment qualification documents such as URS, DQ, IQ, OQ & PQ related to Analytical Development department and conducting audit for cGxP compliance.
Responsible to ensure GxP Computerized Systems at R&D Gurugram (CMC functions) site are in compliance with the current regulatory standards.
Review and support for Computer system Assurance (CSA), Spreadsheet validation, Backups, Audit trail review of software, and lifecycle documentation for computerized systems.
Ensure computerized systems consistently meets the required quality standards throughout its lifecycle at R&D Gurugram (CMC functions) site.
Support on pharmacopoeia updates and new regulations for Analytical Development Department in order to ensure continual improvement in the quality system.
Visiting the AD Labs / Areas for verification of GDP & GMP compliance.
Review of SOPs / GQS / GSOPs / Protocols / Reports / Standard Test Procedure (STP)/Guideline.
Review of scale up data, process robustness and statistical evaluation, technical evaluation for adequacy w. r. t. product development and changes proposed.
Review and assess data based on QBD based approach, to ensure product development data supports to robust product quality through review of documents / scientific knowledge.
Coordinate with cross functional team e. g. Analytical development, Formulation development, Site QA/QC, Project management, Regulatory for successful transfer and filling of product.
Must have strong interpersonal and communication (written and spoken English) skills.

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