Job Purpose
To support the development, evaluation, and qualification of pharmaceutical packaging materials and systems for injectable and OSD products, ensuring product compatibility, quality, stability, regulatory compliance, and cost-effectiveness.
Key Roles & Responsibilities
- Develop and evaluate primary and secondary packaging materials for injectable and OSD products, including vials, ampoules, rubber stoppers, seals, blisters, bottles, closures, and cartons.
- Assess packaging material suitability, product compatibility, barrier properties, and performance under intended storage conditions.
- Coordinate packaging material testing, qualification, container closure integrity testing (CCIT), and other relevant studies.
- Prepare and review packaging specifications, technical documents, test protocols, evaluation reports, and qualification records.
- Support packaging trials, material optimization, scale-up, technology transfer, and commercialization of new products.
- Coordinate with R&D, QA, QC, Regulatory Affairs, Production, Procurement, Engineering, and packaging material vendors.
- Support vendor qualification, alternate material evaluation, change controls, deviation investigations, and CAPA.
- Ensure compliance with applicable GMP requirements, pharmacopeial standards, and regulatory guidelines.
- Identify opportunities for packaging standardization, cost optimization, and continuous improvement without compromising quality.
Educational Qualification
B.Pharm, M.Pharm or a relevant qualification in Packaging Technology, Polymer Science, or a related field.
Experience & Skills
- 5-7 years of experience in pharmaceutical packaging development or packaging material qualification.
- Working knowledge of injectable and OSD packaging systems and material testing.
- Understanding of GMP, packaging specifications, stability requirements, and regulatory documentation.
- Strong analytical, problem-solving, documentation, and cross-functional coordination skills.
Key Performance Indicators
- Timely completion of packaging development and qualification activities.
- Compliance with quality standards and documentation requirements.
- Successful execution of packaging trials and material evaluations.
- Contribution to packaging optimization and cost-reduction initiatives.