Title: Trainee Officer - Quality Compliance

Date: Mar 24, 2023



Location: Tandalja - R&D



Company: Sun Pharmaceutical Industries Ltd

Sun Pharma Global Quality & Compliance Department

Position: Sr. officer /Executive

Department: Corporate Quality Compliance Location: India (SPIL, Vadodara)

Essential Job Functions:

• Registration of Market Complaints in Track wise system & its Classification but not limited to;

Process and analyze product complaints according to Global standards. Evaluation of each complaint for seriousness, correctness and consistency of defect categorization.

• Acknowledge the complaints to the complainant (as applicable) and assist manufacturing site in investigation.
• Follow-up with the complainant for Complaint samples, additional information required to support product complaint investigation.
• Tracking of complaint samples & sending it to the site for investigation
• Coordinate with other stakeholder (PVG, Distribution, RA, Business, Legal etc.) involved in complaint handling process.
• Review of investigations and ensuring corrective and preventive actions in place. Drafting and sharing the responses to the complainant.
• Monthly/ Quarterly Trending of product quality complaints and discussion with sites for actionable.
• Update Global Tracker of Complaint, FAR & Recall and provide the information to relevant stakeholder on ad hoc basis.
• Review the ProPharma data base for US complaints specifically for potential FAR candidates and escalate to responsible personnel for assessment of FAR applicability.
• Monitor the recall process. Verify the reconciliation of recall quantity against the destruction certificate of the recalled stock.
• Assist in Track wise trouble shooting for recall and PQC module.
• Work as a member of a team to achieve all outcomes.
• Perform all work considering the quality themes i.e. drive for growth, innovation & continuous improvement, value creation and excellence in execution, demonstrate strong and visible support of our values.
• Perform all work in accordance with all established regulatory and compliance and safety requirements.
• All other duties as assigned by the reporting manager in accordance with the established responsibilities and compliance requirement.