Manager - Packaging Development

3 weeks ago

Gurgaon, Haryana, India Sun Pharmaceutical Industries Full time

Employee Name NADesignation Research ManagerJob Title ManagerJob Grade G10 G11Department Packaging Development PMD Business Unit DivisionR D-GurgaonManager s Job Title Senior ManagerFLSA Classification NAReporting structureNAVersion and dateJob summary Understanding of pharmaceutical packaging materials components machines and packaging processes Understanding of test procedures and critical attributes of packaging items and compliance with USP EP Understanding of container-closure system and shop floor activities and development of new innovative cost effective pack configuration for US Europe and Canada Adequate knowledge of preparation of packaging documents packaging development risk assessment reports for USA Europe and OAMs Adequate knowledge on development of new packaging change parts designing of pack style and packaging process in accordance to the study parameters regulatory guidelines Development of new packaging change parts design of pack style packaging process in accordance to the study parameters regulatory guidelines Knowledge on development of packaging as an overall skill is desirable Area Of Responsibility Packaging of R D development batches for stability studies as per country regulatory requirements for USA Europe and OAM markets with appropriate documentation and pack configuration Preparation of specifications Test procedures STP Master Production Cards MPCs Study protocols and development reports and Technical Transfer Documents TTD Finalization of packaging materials and packaging performance studies like moisture oxygen permeation seal integrity and transit trial studies Documentation for technology transfer and exhibit batches along with new mould change part development PPS machine feasibility studies and shop floor trials Ensure availability of required packaging materials artworks change parts with related documentation for USA Europe and OAMs Coordination with CFTs and plant functions for smooth execution of exhibit batches at plant locations Support for packaging activities for BE samples in DFL lab Timely revision of SOPs calibration maintenance of lab machines and equipment Proper storage and handling of packaging materials in store Packaging support for commercial launch through development of commercial change parts KLDs Key Line Drawings Artworks and AMS Artwork Management System related activities Packaging support to regulatory for product filling submission and for query response Geographic Scope MarketRegulated markets USA Europe and OAMsBudget if applicable Capex Revenue Work Conditions Not applicablePhysical Requirements Not applicableTravel EstimateNot applicableEducation and Job QualificationPG Diploma in Packaging Engineering Graduation in Science Technology Experience8 to 10 Years of experience in Packaging Development

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