Specialist - Quality Operations (GQS I)

Major accountabilities :

Complaints Management :

• Receive and review the initiated complaints in the QMS tool. 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.
• What you ll bring to the role :
• Minimum Requirements :
• Education :   Pharmacy / Science / MBA / Engineering / equivalent from a reputed institute.

Languages :

Experience :

Skills Required

Regulatory, IT, Quality Assurance, complaints management