Job Description

Department DetailsRole Summary1. To provide Quality oversight on the New tech transfers to CMO's and CTLs. Able to take decisions by connecting with all CFT's on issues arised during tech transfers.
2. To support any new/existing Product developments, regulatory submissions, queries and product launches at or by CMO's.
3. To handle the day to day operations of all CMO's and evaluate the changes/failures notified by CMO's.
4. Responsible for implementing Quality System and Compliance for External Supply Quality function.
5. Develop and implement robust systems related to batch disposition in accordance with local regulatory and international requirements.
6. Responsible for Quality Audits at CMOs triggered by any regulatory bodies, co-ordinate with CMO and provide regular updates and performance of all CMO's to Biocon Management.
7. To participate in review of Health Authority responses by co-ordinating with CMO's
8. Ontime and regular escalations of all CMO's performance to Biocon Management
9. To evaluate and provide Metrics data of all CMO's to Biocon Management
10. Review of Quality Agreements
11. Responsible for handling of Complaints Management at CMO's
12. Responsible for review of Artworks
13. Responsible for review of Supply chain, Transport Validation of all products at CMOs.
14. To interact with all Quality groups with in organization and supporting implementation of harmonized approach across various quality functionsKey Responsibilities1. To provide Quality oversight on the New tech transfers to CMO's and CTLs. Able to take decisions by connecting with all CFT's on issues arised during tech transfers.
2. To support any new/existing Product developments, regulatory submissions, queries and product launches at or by CMO's.
3. To handle the day to day operations of all CMO's and evaluate the changes/failures notified by CMO's.
4. Responsible for implementing Quality System and Compliance for External Supply Quality function.
5. Develop and implement robust systems related to batch disposition in accordance with local regulatory and international requirements.
6. Responsible for Quality Audits at CMOs triggered by any regulatory bodies, co-ordinate with CMO and provide regular updates and performance of all CMO's to Biocon Management.
7. To participate in review of Health Authority responses by co-ordinating with CMO's
8. Ontime and regular escalations of all CMO's performance to Biocon Management
9. To evaluate and provide Metrics data of all CMO's to Biocon Management
10. Review of Quality Agreements
11. Responsible for handling of Complaints Management at CMO's
12. Responsible for review of Artworks
13. Responsible for review of Supply chain, Transport Validation of all products at CMOs.
14. To interact with all Quality groups with in organization and supporting implementation of harmonized approach across various quality functionsSkills:
Technical skills with Manufacturing/Operations back ground and experienced with product introduction, QMS.
Good communication skills and maintain relationship with CMOs
Good presentation skillsEducational QualificationsRequired Education Qualification: Msc
Required Experience: 12 - 15 years

Biocon