Serialization Lead Formulations - Senior Manager / AGM

We are currently looking for an experienced and qualified individual to join our team as a Serialization Lead (AGM).

JD for Serialization HOD Role

1. Candidate must have complete knowledge of global Serialization requirements like US - DSCSA, EU FMD, Russia, China, Emerging countries - Brazil, UAE, Uzbekistan, Kazakhstan etc., and should be a subject matter expert.

2. Candidate must have experience to ensure overall compliances of serialization activities w.r.t. relevant regulatory standards and guidelines.

3. Candidate must have experience in country specific registration activities of EMVO, Tatmeen, GS1, iVEDA etc.

4. Candidate must exhibit good communication skills with internal and external customers / partners for day to day serialization related activities, attend customer concalls for queries & new projects implementation.

5. Candidate must have good knowledge and experience in handling Tracelink application and its various modules of L4 and L5 transactions.

6. Candidate must have experience in handling of on-boarding, testing activities of L4 Tracelink and L3 Optel and Antares system.

7. Candidate must have good knowledge for handling of data management and alert managements for compliances of DSCSA for downstream partners and customers.

8. Candidate should be well versed with the processes related to serial numbers pooling, batches releases in Tracelink, OSM Optel and GTS Antares.

9. Candidate is responsible for supervision of the uploading/transferring the Serialization events (commission, aggregation and shipment events) in Tracelink for different customers/countries.

10. Candidate is responsible for monitoring of software upgradation, qualification and validation of serialization application of L3, L4, L5.

11. Candidate should have sound knowledge in preparing the root cause investigation reports in the event of Serialization related market complaints and implementing appropriate CAPA.

12. Candidate is responsible for monitoring QMS related activities for Serialization, Change controls, Deviations, action plans, CAPA implementation.

13. Candidate must have rich experience to establish various SOPs related to the end to end serialization process flow as per regulated markets requirement.

14. Candidate should be able to handle multiple MSN plants/sites - serialization requirements and must be capable to manage a team by up keeping the evolving regulatory guidelines.