Assistant Manager - Packaging and Development

Role & responsibilities

• Must have knowledge on the development of drug-device combination products.
• Must have experience with injectables, pen injectors, auto-injectors, IV bags, oral suspensions, and solid oral dosage projects.
• Must be knowledgeable about ISO 11608, ISO 11040, ASTM D4169-22, and ISO 10993.
• Must have expertise in preparing design control documents as per 21 CFR 820, including URS, DI, DO, DVT, DVV, DT, and DHF.
• Experience in DQ, FAT, installation, IQ, OQ, PQ, and SOP finalization for drug-device combination product (DDCP) assembly machines is required.
• Must be proficient in the characterization and review of RLD (Reference Listed Drug) pack samples.
• Should be capable of finalizing pack configurations for exhibit batches of new generic products/NDA products as required.
• Expertise in identifying new packaging materials and developing new vendors for packaging materials is necessary.
• Must support the regulatory team in ANDA/NDA filings for regulated markets and assist in responding to regulatory queries.
• Should be adept at preparing and reviewing SOPs, specifications, STPs, MPCs, and BOMs.
• Must prepare and review development study protocols and reports and execute studies effectively.
• Experience in performing functional tests for packaging as per country-specific requirements is essential.
• Should provide support to plants for validation and troubleshooting activities.
• Must be able to prepare packaging documents, such as pack styles and justification reports, in line with product and regulatory requirements.
• Should coordinate effectively with cross-functional teams such as FRD, RAD, FAD, QAD, plant, marketing, BD, and PMO for project activities.

Preferred candidate profile:

Graduate with a professional Degree/Diploma in packaging technology from reputable institute with 8 years of experience in pharmaceutical packaging.