About the job
• *Responsibilities:** • Monitoring of New Product-Packs Commercial Launches. • Monitoring of Existing Product-Packs Revision to comply latest Regulatory / Manufacturing requirement. • Monitoring of Packaging Process Validation. • To monitor / carry out documentation related to Packaging Process Development batches (e.g., Feasibility batches, Optimization batches, scale up batches, Stability batches, Pilot bioequivalence & clinical trial batches, Exhibit batches, Registration batches etc.) as per provided plan & checking / review of related documents. • Facilitation for Procurement and approval of Packaging change parts. • Alternate Vendor Development / Cost effective / Productivity enhancement exercises. • Packaging documentation for routine as well as continuous technology improvement activities. • Responsible for post launch trouble shooting on ongoing commercial products. • Audit / Inspection related activities. • Identify need for fresh guidelines & scope of Improvement & drafting relevant guidelines and ensure its implementation. • Investigation of packaging related market complaints / OOS / OOT / Deviation & implementation of corrective and preventive actions as required. • SOP creation/revision and implementation. • Review & approval of SOP. • Supporting R&D and Plant for technology transfer of Packaging. • Support and execution of site transfer products. • Resource planning / Work assignment / Job allocation. • Ensuring Quality compliance as basis for all documentation. • Budgeting (Revenue, Capital, IT and Manpower). • Review and approval of QMS related records from Track wise. • Exploring Developmental training for subordinate’s development. • Attending CFT and QRB meetings, drawing action plans and ensuring its smooth implementation. • Review & approve the artwork (For filling / trial / commercial product). • Co-ordinate with CFTs and machine manufacturer to resolve the related issues of packaging machinery. • Co-ordinate with CFTs and supplier / manufacturer of packaging material to resolve the material related issues. • Co-ordinate to ensure the URS as per packaging material / current regulatory guidance. • Co-ordinate to ensure the timely completion of FAT / SAT of new equipments. • To ensure the smooth operation of equipment. • To identify the new equipment as per plant requirement. • Co-ordinate to ensure the respective documents for smooth operation & filling of new drug product (MPC / Pack Style / EBPR / IBPR / SPEC / ATP). • To review the trial reports and other developmental documents.
About the company
Sun Pharma is a global leader in specialty pharmaceuticals, dedicated to providing innovative and quality-driven medicines.
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