
Product Development Specialist
1 week ago
Purpose:
Develop new products and enhance existing formulations for regulated markets. Product lines include Solid and Liquid Dosage forms such as Tablets, Capsules, Solutions, Suspensions, Pellets, and MUPS.
Key Responsibilities:
- Understand project scope, define activities, and timelines to ensure timely completion.
- Lead the development of new formulations by investigating API characteristics, safety, and compatibility.
- Identify resource requirements for projects, including materials, manpower, and machine change parts.
- Develop R&D plans and experimental designs using QBD principles.
- Plan and coordinate lab-scale up, optimization, and pilot BE batches while adhering to lab GMP practices.
- Review lab experiment notebooks and prepare technology transfer documents.
- Liaise with technology transfer teams and production sites for seamless technology transfer.
- Program for product performance optimization by investigating API characteristics and finished products.
- Monitor stability studies and evaluate results for product development.
- Liaise with various departments, including project management, analytical development, and supply chain teams.
- Prepare departmental SOPs, manuals, and guidelines documents.
- Monitor IQ, OQ, and PQ activities of new machines and ensure proper functioning and maintenance.
- Train subordinates, technicians, and housekeeping personnel on equipment and systems.
- Maintain raw materials and finished goods storage and inventory records.
- Participate in departmental audits and ensure compliance.
- Stay updated on the latest developments in technology, conceptual thinking, presentation, and communication skills.
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