Title:  Executive/Senior Executive

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 failure 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.