30/04 Girish
Recruitment Manager at Venus Consultancy

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Executive - Regulatory Affairs/Quality Assurance - Drug Eluting Stent Manufacturer (4-7 yrs)

Mumbai Job Code: 9846

1. Ensure Implementation & Effectiveness of QMS. Prepare&/ Review, Implement and maintain all QMS documents (QMM, Quality plans, specifications, formats,procedures etc.) as per latest ISO versions & applicable regulatory requirements and ensure timely updation. Controlled Issuance & Retrieval.

Review & approve changes through effective change control process.

2. Periodically Review & Manintain MR documents.

3. Maintain Packing Art File. Allocate & Revise numbering system as required.

4. Plan & Conduct Internal Quality Audits with assigned team. Prepare IQA Reports.

5. Plan & Conduct Management Review meetings based on fixed Agendas. Prepare minutes of MRM and MRM output reports. Follow up.

6. Review & authorize Goods received notes, Production & Packaging Plannings.

7. Execute Line clearance activities for production & Packaging departments.

8. Monitor/Review Inprocess Activities & reports & ensure cGMP in plant.

9. Review Finished product testing reports, Batch Manufacturing Records & execute Batch Release activity issuing Batch Release certificate.

10. Ensure Periodic Validation & Re-validation. Review DQ/IQ/OQ/PQ activities.

11. Ensure Periodic Calibration of Equipments/Instruments (Inhouse/external).

12. Assist in investigation of Deviation, Incidents & OOS.Ensure effective CAPA taken as & when necessary and timely closure of deviation & OOS.

13. Handle Customer Complaints. Analyse with QC & Production team. Prepare Complaint Evaluation Report & communicate to customers.

14. External Service Providers Agreements & timely renewal. Onsite Audit of external service provider with QAQC-Head

15. Assist in preparing & updating Device Mater Files, Technical Files, Site master file, CTD

16. Regulatory Applications: GMP, Manufacturing license, License Renewal, Test license, Import license, free sale certificate & wholesale license, CE certification, recertification, Clinical Trials, Animal trials. SUGAM PORTAL.

17. Regulatory product registration dossiers for various countries.

18. Liasioning with critical suppliers and with representatives of ISO & CE notified bodies for documents, audit related follow-ups or as and when required.

19. Actively involved in R & D : Assist in Animal Trial protocols, Clinical Trial Protocols,CRF, ICF etc. preparation.)

20. Assist in preparing PMS, PMCF & Clinical Evaluation protocols & Reports.

21. External Audits faced: CE & ISO announced- Surveillance, Recertification, CE

Notified body- Unannounced, FDA/CDSCO joint inspection for new products,renewal of license, GMP, unannounced FDA inspections. Third party Audits for OBL- BSI & UDEM notified body unnounced audits. Audit Follow-ups.

Dr Ruchir Joshi,

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