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Job Details

Computer System Validation (CSV) - Large Pharma

Company: TEC Group International
Reference: MGGOLPCSV
Closing Date: 28 Feb 19
Type: Contract
Salary (£): Negotiable

Job Summary:

Freelance CSV / Contract CSV / Computer System Validation / Software Validation Engineer / Compliance Consultant - You will be responsible for validation of a wide range of software, equipment and processes, you will generate and execute validation documentation to ensure GxP compliance. You must have a degree or higher in computer science/ engineering or related discipline. Also must have experience in Auditing, validation and Regulations.


Freelance CSV / Contract CSV / Computer System Validation / Software Validation Engineer / Compliance Consultant

I am currently working with a top 10 Global Pharma company who are dedicated to increasing patient access to new medicines and treatments. They focus on a wide range of medical disciplines and therapeutic areas. They aim to set the standard for quality of healthcare products, resulting in you having a massive impact and influence within your department despite it being a large company.


  • Degree or higher degree in Computer Science, Engineering or related discipline
  • Some knowledge of clinical data management process for FDA regulated companies is a plus. Familiarity with FDA regulations such as 21 CFR Part 11 and GxP desirable
  • Desirable 3+ years’ experience in GMP environment
  • Ideally knowledge of the following:
    • 21 CFR Part 11
    • 21 CFR Part 210, 820
    • Annex 11
    • GAMP 4/5 Guidelines


Responsibilities (include but not limited to)

  • Validation of a wide range of software, equipment, processes and spaces
  • Execute and report validation protocols in line with Quality and Health & Safety
  • Ensure GMP compliance in the validation activities and documentation
  • Coordination of validation projects and manage external contractors
  • Responsible for the regulatory compliance and validation of businesscritical systems including quality management systems, process / control systems
  • Generation and execution of validation documentation

My name is Megan, I am a consultant specialising within Quality Assurance, to find out about this opportunity, similar opportunities or get expert advice regarding your next step contact me via:

Phone: +44 2085443429




Apply for this job: Computer System Validation (CSV) - Large Pharma

Contact Information:

Address:  Head Office
Dowgate Hill House, 14-16 Dowgate Hill, London
Tel:  +44 (0) 208 544 3400
Website:  Visit Our Web Site

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