Title:  Manager - 2 - Office of Data Reliability

     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:

1. 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.
2.  Review of supporting documents like user log books, attendance records & electronic data, if any, (related to documents/data meant for USFDA submission).
3. During review, ensure the compliance of employee Certification for all documents (R&D related data) intended for USFDA regulatory submission.
4. Coordinating with stakeholders (Regulatory affairs, Analytical research & Product/Packaging development research etc.) for raw data for ODR review.
5. Critically review R&D related deviations (if any) during pre-submission review of documents/data related to filing for USFDA.
6. Audit the pre-submission data and report any non-compliance activities to immediate Manager.
7. Documentation of pre-submission audit checklists and worksheets of the product.
8. To scan, review, and load the documents/data in Laserfiche and promote to ODR Manager with audit checklists and worksheets.
9. 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