Senior Executive

Job Description

Job Role : ODR Auditor Designation : Manager (G11A)/Sr. Executive ODR Department & Sub Area (If applicable) : Office of Data Reliability (Gurugram) Accountabilities: This position is accountable for critically reviewing data and documents generated by Analytical Research Department and Product/Packaging development department which are meant for submission to USFDA and ensure the data integrity and accuracy of all documents ready for submission. Responsibility: Perform thorough review of raw data (pertaining to R&D related activities (viz. Analytical Method Validations /Analytical reports / Analytical Method Transfer / Product Development Report etc. ) compiled by respective department & already reviewed/approved by R&D Quality/QA and ensure the accuracy, completeness and integrity of data/document meant for regulatory submission to USFDA. Review of supporting documents like user log books, attendance records & electronic data, if any, (related to documents/data meant for USFDA submission). During review, ensure the compliance of employee Certification for all documents (R&D related data) intended for USFDA regulatory submission. Coordinating with stakeholders (Regulatory affairs, Analytical research & Product/Packaging development research etc. ) for raw data for ODR review. Critically review R&D related deviations (if any) during pre-submission review of documents/data related to filing for USFDA. Audit the pre-submission data and report any non-compliance activities to immediate Manager. Documentation of pre-submission audit checklists and worksheets of the product. To scan, review, and load the documents/data in Laserfiche and promote to ODR Manager with audit checklists and worksheets. Any other responsibilities which are appropriate and/or assigned by the department head. Education and Job Qualification: Minimum of a Bachelor degree in Pharmacy, Chemistry or related field. Experience: 08-12 years Industry: Pharmaceutical Experience: Experience in analytical laboratory having handled the latest analytical instruments Knowledge of GxP, cGMP and regulatory requirements ICH / USFDA guidelines Knowledge of QC Laboratory test procedures, Method validation, and Analytical method Transfers, API & Finished Products testing procedures and Stability testing procedures. Strong skill to review the Laboratory data including data in electronic format