CSV Engineer

19 hours ago


Pune, Maharashtra, India PRIMUS Techsystems Full time ₹ 5,00,000 - ₹ 15,00,000 per year
Dear All,   As discussed ,please find below JD for your reference. 
Job description: -  Consulting and support services for compliance, validation, Computerized System Validation, IT Infrastructure Qualification and IT Solutions Pharma, Biotech, life sciences industry for Computerized System Validation's;      Responsibilities: -  Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.     Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.      Experiences: -  Bachelor's degree in engineering science years of work experience is a must.  Key skills   Process automation, Technical writing,  GCP, Project management, Pharma, Writing skills, Consulting, GLP, Life sciences, GMP       Computerized System Validation CSV, US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.   Good communication and technical writing skills are a must.
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