CSV Specialist

Drug Development Solutions (DDS) is a Contract Research Organisation (CRO) that helps drug development and consumer healthcare companies develop medicines and products to improve the quality of life. Here in the UK, our Fordham and Sandwich sites we employee over 300 people, with more than 200 dedicated scientists.

With one of the world’s largest bioanalytical centres, recognised for leadership in science and technology, DDS has comprehensive capabilities for pharmacokinetic, immunogenicity and biomarker measurement that span LC-MS/MS, immunoassay and flow cytometry.  We routinely solve difficult method development challenges and have the capacity to support the largest, most complex protocols.

Our Bioanalysis Department works together with pharmaceutical and biopharmaceutical companies in support of pre-clinical and clinical trials for a wide variety of clients and therapeutic areas. We use innovative analytical methodology and the expertise of our analytical scientists to speed up the discovery of new medicines.

Our Analytical and Materials Science Solutions Department is a team of problem solvers ready to partner with pharmaceutical and consumer healthcare companies to support development, validation, and application of testing methods.

DDS operates well-equipped laboratories compliant with GLP, GCP and GMP, and offers the opportunity to work with state of the art analytical instrumentation

This role is based at either Fordham, Cambridgeshire or Sandwich, Kent UK within Drug Development Solutions (DDS).

The role

We are looking to recruit an experienced CSV Specialist to bring into our team based at Fordham or Sandwich sites.

You will have full autonomy in making decisions that drive the CSV processes and priorities forward.

You will have the capacity to grow the role into one that supports the business on a Global scale.

Responsibilities

  • Championing full lifecycle validation for all applicable computerised systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance.
  • Leading on the Validation of business systems.
  • Working effectively with project teams to compile user requirements for local and group software systems.
  • Using quality risk management to deliver scalable approaches to CSV.
  • Working with system vendors to leverage appropriate information and documentation into CSV activities.
  • Designing, compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles.
  • Keeping up to date with advances in the CSV field, regulatory requirements and good practice guidance.
  • Delivering compliant validated systems by design.
  • Coaching and mentoring the CSV team members to support their CPD and ensure the efficient and effective delivery of services back to the business.

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