Job Description

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

Sun Pharmaceutical Industries