Novo Nordisk is a global healthcare company with 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases.
Job Title: Senior Quality Associate
Location : Bangalore
Key responsibilities of the position:
- Draft local quality procedures and Maintenance of master list of the affiliate
- Act back up for reporting Customer Complaints within the timelines and Follow-up information to be collected, compiled and reported within the timelines
- Initiate, Implement and Follow-up for completion of Change Control, Document control, Change Request
- Expert and QA Approver. Review and Approve Non conformities. Follow-up on action plans and close within the timelines.
- Review and approve the Batch documentation of Repackaging.
- Prepare, plan, implement and close and submit the QAP report annually within the set timelines.
- Release of imported products and contract manufactured products and Data Maintenance
- Prepare audit plan and conduct audit at distributor’s warehouse and self-inspections within the Affiliate.
- Prepare, Distribute and Follow up on audit findings.
- Review and approval of the validation protocol for all the temperature distribution study conducted in the distributor’s sites
- Review for necessary approvals and document the destruction of NN products
- Verify clinical expedited safety reports before reporting to concerned Indian regulatory authorities and QC of regulatory submission
- Responsible of handling the business critical documents
Education requirements : Post Graduation in Pharmacy/Science preferably trained in ISO Standards and / or Certified and Experienced Lead Auditor with minimum of 5 years of relevant experience working in quality and audits or minimum 5 years overall experience in pharmaceutical industry with 2 years’ experience in NN