Deputy Manager - Disposables Product Development

Should have Knowledge in :

a. Pharmaceuticals and Medical Devices

b. Product development

c. Chemical (All) knowledge

d. Drug Medical Device Development

e. Sterilization stability studies

f. USFDA, CE Mark

Responsibilities :

- Responsible for disposables product development

- Plan and execute disposables product development projects including development of solutions

- Development of new solutions including specifications, process, test methods, testing, validation and stability programmes

- Developing sterilization cycles, stability verifications, evaluating impact of design and packaging changes on sterilization / stability, solutions specifications at release / end of life

- SME for solutions and whole blood products containing solutions

- Ensure compliance with all ISO standards, product documentation, specifications, SOPs and Regulatory requirements, as required

- Effectively utilize resources and manage activities within budget as per functional cost centres.

- Partner with Marketing team and Manufacturing team, customers and vendors to support new creative ideas in the area of disposables and solutions development.

- Collaborate with global cross functional teams as required

Knowledge on Pharmaceuticals and medical devices including Materials, Development, Manufacture and Quality. Thorough knowledge on Pharmaceutical ingredients and their interaction, solutions preparation, sterilization, stability studies, test methods development, validation, quality control and Good Documentation Practice. Proven leadership, knowledge on QMS, Regulatory requirements and working in collaboration with global teams

Experience : 8-10 years of experience in Pharmaceutical/Medical device Industry

Qualification : Masters in Pharmacy

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