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Job Details

Computer System Validation (CSV) - Small Biotech

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

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.

Requirements:

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

I am currently working with an Innovative Biotech that continuously challenges itself to heighten its standards and accomplishments. They Pride themselves on having an excellent culture built with the sharpest minds in Biotech, resulting in a close community where you can see the tangible results of your contributions. Every individual matters to my client, with everyone having a chance to enhance their skills through ongoing development. This company allows you to get stuck into multiple areas with a variety of work to expand your experience.

Qualifications/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

Email: mgoodwin@tgilifesciences.com

LinkedIn: linkedin.com/in/megan-g-821459103

Apply for this job: Computer System Validation (CSV) - Small Biotech

Contact Information:

Address:  Head Office
Dowgate Hill House, 14-16 Dowgate Hill, London
EC4R 2SU
England
Tel:  +44 (0) 208 544 3400
Website:  Visit Our Web Site

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