Analyst Quality Operations

Major accountabilities:

• Process / Send technical complaints to CMO / Supplier for investigation. Co-ordinate for complaint sample availability, additional information from Country Organization (CO) to CMO (Contract Manufacturing Organization) and vice versa as and when required.
• Periodic follow of complaints with supplier for timely investigation. Perform queries in QMS tools like GxQEM as per the procedures.
• Reviewing of supplier investigations and completing it in QMS tool for complaints delegated to GQSI.
• Perform the role of QA approver for complaints delegated to GQSI. Tracking and extension of complaint / actions as per the requirements.
• Complete the assigned tasks as per business need. Management of Child records such as Investigation, Communication action etc. as per the requirement.
• Participate in meetings / discussions between sites and suppliers over supplier complaints as and when required.
• Perform Quarterly complaint/ deviation trending and reporting. Evaluation of Signals and further management in QMS tool.