Packaging Development Executive

Role & responsibilities

Understanding of pharmaceutical packaging materials, components, machines and packaging processes.

• Understanding of test procedures and critical attributes of packaging items and compliance with guidelines
• Understanding of container-closure system and development of new, innovative, cost-effective pack configuration.
• Adequate knowledge of preparation of packaging documents, packaging development & risk assessment reports.
• 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

1. Packaging Development of R&D development batches for stability studies as per country & regulatory requirements for Regulated /Semi regulated Markets with appropriate documentation and pack configuration.

2. Preparation of specifications, Test procedures (STP), Master Production Cards (MPCs), Pack Styles, Study protocols and development reports, and Technical Transfer Documents (TTD)

3. 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. Change parts FAT/SAT, machine feasibility studies and shop floor trials.

4. Ensure availability of required packaging materials, artworks, change parts with related documentation.

5. Coordination with cross-functional teams and plant locations for smooth execution of exhibit batches

6. Packaging support for commercial launch through development of commercial change parts, KLDs (Key Line Drawings), Artworks and AMS (Artwork Management System) related activities

7. Packaging support to regulatory for product filling / submission and for query response

Education and Job Qualification

PG Diploma in Packaging / Engineering / Graduation in Science / Technology.