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Job Location | Ahmedabad |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | IT - Software |
Functional Area | General / Other Software |
EmploymentType | Full-time |
Computerized System Validation (CSV) Specialist Job Profile IVYWORKS is a Compliance Consulting firm. We provide services to pharmaceutical and biotechnology industries. Visit http://www.ivyworks.net for more info. 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. Experience Bachelors degree in engineering / science. 2-6 years of work experience is a must. Experience/exposure to 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. Job Location Our Office is located in Bangalore and the job may involve travel to client locations. ,
Keyskills :
laboratoryautomation gmp it eu glp usfda fda 21cfr writingskills processautomation writing cfr computerizedsystemvalidation computerizedsystems gcp gamp visit technicalwriting complianceconsulting tatementsofworksow