Job Description

Employee Name:
NA
Designation:
Research Manager
Job Title:
Manager
Job Grade:
G10 / G11
Department:
Packaging Development (PMD)
Business Unit/ Division
R&D-Gurgaon
Manager's Job Title:
Senior Manager
FLSA Classification:
NA
Reporting structure
NA

Version and date
Job 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/ Market
Regulated markets USA, Europe and OAMs
Budget (if applicable)
Capex: Revenue:
Work Conditions:
Not applicable
Physical Requirements:
Not applicable
Travel Estimate
Not applicable
Education and Job Qualification
PG Diploma in Packaging / Engineering / Graduation in Science / Technology.
Experience
8 to 10 Years of experience in Packaging Development