Manager - Office of Data Reliability

As Manager - Office of Data Reliability at Sun Pharmaceutical Industries Ltd, your role involves critically reviewing data and documents from Analytical Research and Product/Packaging development departments for submission to USFDA. Your responsibilities include: - Perform a thorough review of raw data related to R&D activities such as Analytical Method Validations, Analytical reports, and Product Development Reports to ensure accuracy and integrity for regulatory submission. - Review supporting documents like user log books and electronic data related to USFDA submission. - Ensure compliance with employee Certification for all R&D data intended for USFDA submission. - Coordinate with stakeholders for raw data required for ODR review. - Critically review R&D deviations during pre-submission of documents for USFDA filing. - Audit pre-submission data and report non-compliance activities to the immediate Manager. - Document pre-submission audit checklists and worksheets of the product. - Scan, review, and load documents/data in Laserfiche and promote to ODR Manager with audit checklists and worksheets. - Fulfill any other appropriate responsibilities assigned by the department head. Qualifications required for this role include: - Minimum of a Bachelor degree in Pharmacy, Chemistry, or related field. - 8-12 years of experience in an analytical laboratory with knowledge of GxP, cGMP, ICH/USFDA guidelines, QC Laboratory test procedures, Method validation, Analytical method Transfers, API & Finished Products testing procedures, and Stability testing procedures. - Strong skills to review Laboratory data including electronic formats. Join Sun Pharmaceutical Industries Ltd and contribute to ensuring data integrity and accuracy for USFDA submissions.,