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Company Name : Cipla
Location : Vikhroli, Mumbai, Maharashtra
Position : Team Member – ROC
Job Description : Division
IPD
Department
Formulation R&D
Employment Type
Permanent
Job Purpose
To review Drug History File prepared for standalone medical device, and device constituent parts in accordance with country specific regulatory guidance in stipulated time.
To review Technical package or DHF of respiratory combination product document throughout the development and life cycle of the project.
To monitor quality management system for Medical Device and Insilco lab.
To prepare SOPs related to drug/device combination product and standalone medical devices.
Accountabilities
Review of Drug History File (DHF) prepared for standalone medical device, and device constituent parts in accordance with country specific regulatory guidance in stipulated time and individual documents related to DHF such as study protocols, report, design input ,Design output ,Design Verification etc.
Review Technical package or DHF of respiratory combination product throughout the development and life cycle of the project.
Monitoring quality management system for Medical Device and Insilco lab.
Preparing SOPs related to drug/device combination product and standalone medical devices.
Education Qualification
M.Sc. (Analytical or Organic or Inorganic) or M. Pharm
Relevant Work Experience
Minimum 3-4 years of Respi. ADL experience. Good communication and co-ordination skills , Analytical knowledge about Respi analytical techniques.
Competencies/Skills
Communication Skills (clarity of thought, comprehension)
Likely potential for growth
Job / Product / Technical Knowledge / Pharma domain knowledge
Presentation & Interpersonal skills (If applicable)
Managerial or People Management skills
Safety awareness (If applicable)
Relevance of Previous Experience
Comprehension, Analytical & Problem solving abilities
Productivity & Result Orientation (If applicable)
Attitude
Qualification fitment
Sales drive (If applicable)
Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.)
Job Location
Vikhroli
This post is listed Under Mumbai jobs
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