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Expired
  • Location: United Kingdom
  • Salary: Competitive
  • Job Type:Permanent

Posted over 2 years ago

  • Sector: Quality
  • Contact: Adrienn Prezenszki
  • Contact Email: adrienn.prezenszki@nextphaserecruitment.com
  • Contact Phone: 01403 216216
  • Start Date: 2021-11-25
  • Job Ref: V-47108
A brand-new permanent opportunity has arisen within an award-winning global organisation leader in randomization and trial supply management (RTSM) for the global life sciences industry through increased client demand.

Company Description
Our client is an exciting scale up Software Solutions Provider working at the cutting edge of clinical trials technology. This newly created permanent role will be a fantastic opportunity to become part of a company with an aspirational culture, a defined career path and a leadership team who are open to new ideas and like to say yes!

Given that you can work largely remotely, you can be based in either East Coast US, UK, or Mainland Europe, though you must be willing to travel if required.

The Role
To ensure all validation and activities for core products and study related projects are planned and documented and will provide Quality oversight for testing during the overall validation processes. You will also ensure validation and data security of the overall infrastructure for study developments.


Key Responsibilities:

  • Ensure all computerized systems are appropriately validated including tools, products and studies.
  • Maintain awareness of data management, validation, and data integrity needs in a GCP regulated environment.
  • Help project teams define appropriate computerized systems validation strategies, including testing approaches and identifying appropriate objective evidence.
  • Assist in identifying and validating internal tools that have a GxP impact.
  • Review and/or approval of Validation Plans and Reports.
  • Assist in scoping validation efforts based on a corporate risk management approach.
  • Review and approve test executions performed by the Software Test Analysts during study validation activities.
  • Work closely with DevOps to ensure requirements for electronic data security and infrastructure validation is comprehensive and complete.
  • Participate in audits as a CSV subject matter expert. Assist in the training of CSV requirements to all areas of the company.
  • Assist in the development and maintenance of validation-related procedures and deliverables in Quality.
  • Evaluate CAPAs to identify areas of improvement for validation.
  • Report regularly to Quality management on the validation efforts and deliverables.
  • Assist other departments with tasks as appropriate.
 
Experience
You need to have a Bachelors degree in life sciences or engineering or in a similar field. You will have minimum 5 years’ experience in Computer Systems Validation or Quality – related position in a regulated environment. You will have knowledge of GAM[, risk based approach to validation and 21 CFR Part 11 as well as knowledge of FDA, GCP regulations.