CSV Specialist1

1 day ago


Pune, Maharashtra, India PRIMUS Techsystems Full time ₹ 5,00,000 - ₹ 15,00,000 per year
Computerized System Validation CSV Specialistnbsp;
Bachelors degree in engineering science
2 5 Years
Key skills Process automation,Technical writing,GCP,Project management,Pharma,Writing skills,Consulting,GLP,Life sciences,GMP
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 Validationnbsp;
Responsibilitiesnbsp; Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP ; 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 ;
Experiencenbsp; Bachelors degree in engineering ; 2 5 years of work experience is a ;
Computerized System Validation CSV, US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.nbsp;
Good communication and technical writing skills are a ;