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:
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
