Senior Executive

Job Description

Job Role : ODR Auditor Designation : Manager (G11A)/Sr. Executive ODR Department & Sub Area (If applicable) : Office of Data Reliability (Mohali) Accountabilities: This position is accountable for critically reviewing any data and documents generated in Quality Control Laboratory as well as executed Batch records which are meant for submission to USFDA and ensure the data integrity and accuracy of all documents ready for submission. Ensure during pre-submission review of all data pertaining to submission to USFDA that all Finished products, Drug Substances, Intermediates, Raw materials and Packaging materials are tested as per approved procedures under cGMP conditions and documented precisely in raw data sheet or respective Lab notebooks. Responsibility: Perform thorough review of raw data (meant for filings to USFDA) compiled & already reviewed/approved by QC analytical data reviewers and QA and ensures the accuracy, completeness and integrity of data/document meant for regulatory submission to USFDA. Thorough review of executed Batch Records (meant for filings to USFDA) which are already reviewed and approved by 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) viz-a-viz the activities with executed documents prepared by quality control as well as manufacturing/packaging activities reported in executed BPRs. During review, ensure the compliance of employee Certification for all documents (analytical and manufacturing) intended for USFDA regulatory submission. Critically review the Analytical and Mfg. deviations (if any) during pre-submission review of documents/data related to filing for USFDA. To scan, review, and load the documents/data in Laserfiche and promote to ODR Manager with audit worksheet. Documentation of pre-submission audit worksheets (loaded in Laserfiche) of the product. 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