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Job Details

Computer System Validation (CSV) - Small Pharma

Company: TEC Group International
Reference: MGGOSPCSV
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 client who delivers innovative and life changing drugs, with a culture massively focusing on the patient coming first and improve their lives worldwide. The unique products and innovative approaches to treatments of disease is just one of the many things that defines my client. This company allows you to get stuck into multiple areas with a variety of work to expand your experience.


  • 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) - Small 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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