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Computer System Validation Specialist

Reference Number: 920962 | Salary: Competitive | Location: West Sussex, United Kingdom | Division: Scientific Permanent


Computer System Validation Specialist
West Sussex – Medical Devices
Competitive Salary

 

Our client is a fast growing medical device business with over 60 years’ experience in being a specialised manufacturer. Due to continued growth in the business and a recent move to new premises out client is now looking for a CSV Specialist to join the business. 


The objectives of this role are to help the implementation of Computerised Systems across the business which will be used to drive efficiency improvements and work in partnership with a number of departments such as IT.

 

Responsibilities and Performance Indicators

  • Determining validation requirements for computerised systems and manufacturing systems in accordance with a risk based approach
  • Provide technical input into regulatory submissions / regulatory enquiries
  • Provide guidance to project teams
  • Preparation and completion of validation documentation / protocols
  • Establishing a professional relationship with suppliers

 

  • Producing documentation to the required quality and agreed timelines (validation plans, validation protocols, testing rationales, reports, etc.)
  • Reviewing and approving supplier’s documentation to the required quality and agreed timeline
  • Raising awareness of CSV across all levels of the company

 

Experience

  •  
  • Minimum 2 years’ experience within a CSV (Computer Systems Validation) role or equivalent
  • Working knowledge of ERP systems and other business systems
  • Working knowledge of GAMP5
  • Experience working within the Medical Device, Pharmaceutical or similar regulated industry

 

  •  
  • Working knowledge of 21 CFR Part 11 and Orange Guide Annex 11

 

Please click apply now to find out more!

 

Harris Lord is acting as an employment agency for this opportunity

Keywords: validation, CSV, computer system validation, computer systems validation, validation, medical devices, medical device, IOS13485, CFR, GAMP5, ERP, Pharma, Pharmaceutical, regulated, 


Contact: Josh Hemsley

Keywords: Keywords: validation, CSV, computer system validation, computer systems validation, validation, medical devices, medical device, IOS13485, CFR, GAMP5, ERP, Pharma, Pharmaceutical, regulated,


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