Job Description

Responsibilities/Duties

• To plan and schedule Product Development activities in coordination with the New Product Development Committee.
• To allocate the responsibilities to the staff on the projects for product development.
• Lead and guide the team in product development and resolving technical issues.
• Project planning, resource planning and budget planning.
• To identify the tools required for new product development.
• To identify the packaging materials that will ensure the proposed stability of the products.
• Lead cross-functional scientific and technical teams in all aspects of project initiation, planning, execution, monitoring and closure.
• To review the stability data for the PDL stability batches.
• Conduct periodic internal reviews and document verification in the department.
• To give inputs for the preparation of artwork and review the artworks.
• To coordinate with the related Departments for the Manufacturing of Validation and Scale-up batches.
• Troubleshooting of commercial batches and review of a manufacturing procedure for the existing products.
• Review the technical documents related to Product Development and the Batch Manufacturing Records.
• Technical support for Vendor development and qualification of Raw materials and Packing materials.
• To review the deviations and change control documents.
• Coordination with other Techno-Commercial Departments to get/provide timely functional support.

Competencies

Teamworkorientedandmulti- tasking, well-spoken and written English.Knowledge of PDLand production machinery.

Skills

Basic computer skills of MS Word, ExcelandPowerPoint

Knowledge

• CurrentGoodManufacturing Practices (cGMP)
• ICHguidelines GCC guidelines
• Knowledge of technology Transferofalldosageforms

Experience

15-20 years experience in pharmaceutical product development

Education

BachelorDegree in Science/Pharmacy