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:
Fluent in English (written and spoken)
Good communication, presentation, and interpersonal skills
Experience:
Minimum 7 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices
GxP knowledge, Basic IT knowledge
Experience of working closely with the global stakeholders
