Senior Manager

3 weeks ago

India Biocon Full time

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

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