Sr Product Transfer Manager
Mumbai, Maharashtra, India
Job Description
Project Management of and participation in, technical transfer activities with associated document authoring and review, including Project budget planning and control.
Provision of technical support and expertise to all relevant activities within the business unit
Project management of assigned projects including to monitors execution of product supply integration plan from Global Operation perspective; highlight risk and issues (with propose mitigation plan) to line manager that could impact on continuity of product supply during transition period from seller.
Authoring, review and approval of technical documentation (BMRs, technical reports and summaries, etc) to support manufacturing & regulatory activities
Review and approval of sections of Regulatory Dossiers (Module 2 and Module 3) in CTD format for use in all submission related activities
CMO site attendance as required to resolve manufacturing/technical issues affecting continuity of supply of products
CMO site attendance to support key strategic initiatives such as Technical Transfer of Products and Processes, introduction of new APIs or any other projects requiring Technical Support or Project Management.
Other tasksOther tasks as delegated by Line Manager which contribute to overall running of the business unit
