Senior Manager.

Arrange the samples of API along with working standards, Impurities and documents such as Specification, STP, impurity cl-assification and Nitrosamine impurities risk assessment report (Full Kit) for the approved New Development Projects/Site Transfer/In-Licsensed Projects Sourcing of RLD from Global Market (Mainly from US, Europe and Australia) and arranging the timely delivery. Procurement of Excipients, Flavors, Colors etc. for Trial and Validation quantities from validated and licensed sources for new product development/Site Transfer Projects. Responsible for process of CDA before initiation of any pre-requisite documentation and then arranging Technical Agreement once project moves. To provide end-to-end support to F&D/MS&T/ASD/CQA/RA/IP and other CFT members in providing regulatory documentation support, technical data, vendor query response. Work cohesively with vendors & QA/Legal teams for vendor qualification, Audit and Technical Agreement. Timely processing of open requisitions to Purchase order issuance and delivery at respective plant locations for the materials required for Trials and validation batch execution. Strong Cost and Value orientation in all decisions and transactions. Follow up and collaboration with Logistic team for custom clearance of import materials. Co-ordinate with Stores Team for Goods Receipt Note posting and submission of Original Invoice to SSC and follow up for release with Finance and SSC team for due payments. Attend to quality related issues and deliver replacement materials without any hampering plant production activity. To maintain a detailed tracker for all the New Development/ Site Transfer projects. Handling the procurement related to R&D /MS&T and working for Strategic Sourcing Team . New Product Development/ Site transfer projects /Alternate Vendor development ( Excipients) Identification and qualification of Sources for new excipients. Getting Pre-requisites and sharing the same to CFT’s towards excipient qualification including Sample arrangement, Trial quantities, Vendor qualification documents and Analytical requirements. Co-ording with approved Commercial Excipient Sources for any technical queries pertaining to New Development. Material Procurement for Scale-up and Exhibit batches: (Excipients) On receipt of material requirements, quantities to be planned from commercial stock for existing excipients through Commercial Planning team for material sparing. Initiating procurement process for new material requests which are to be procured with effective negotiation on - Pricing, MOQ, Payment terms & freight charges. Coordinating with suppliers to ensure timely deliveries. Arrange material delivery status to project management on weekly basis. Technical, Regulatory requirements, Quality Compliance (Excipients) Facilitate support from Vendor on technical requirements received from FD and MS&T. Coordinating with vendors to fulfill the ANDA filing requirements for exhibit batches. Coordinating with CFT teams for vendor qualification and approval.