CSV Consultant – Hybrid role with travel – Need to have EU work Authorisation

Talent Partners are currently looking to hire a CSV Consultant for a global consultancy player in the life sciences industry, as they enable client companies to adopt technological transformations within a regulated environment.

The (CSV) Consultant will have the versatility and confidence to work on individual assignments, and collaborate in team environments as when required, to deliver Computerised System Validation (CSV) and Data Integrity (DI) programmes and projects. This role will see you working with the leading industry players across the globe, predominately in a remote working environment, with occasional visits to client sites as and when required.

Role Purpose:

The purpose of this position is to ensure that client’s requirements are translated into effective quality and compliance services and that solutions are delivered in the most optimum way.

Role Requirements:

  1. To support the conduct of Computerised System Validation (CSV) and Data Integrity (DI) programmes/projects in accordance with client requirements., regulatory requirements, and industry best practices.
  2. To support programmes/projects/work packages in accordance with agreed plans to the satisfaction of customers.
  3. To support subject matter experts within programmes and projects to ensure the most appropriate and effective customer solution.
  4. To continuously develop skills and competencies within CSV.
  5. To become a recognised industry subject expert through participation in industry organisations (e.g., ISPE) and events (publications, conferences, and blogs).
  6. To establish effective client relationships to generate new business opportunities across our client’s business service area.

Key Deliverables:

  1. Be a team player, providing support where necessary to colleagues.
  2. Clear communication skills to provide direction, communicate expectations and articulate opinions and solutions.
  3. To be able to create clear and concise documents.
  4. To support excellent customer relationships to secure business continuity.
  5. To be able to manage/assist projects within agreed timelines.

Knowledge & Experience:

The successful candidate should be able to demonstrate a practical level of experience in all aspects of CSV projects including:

  1. Supplier Audits and Assessments
  2. Risk based Validation Planning and Reporting.
  3. Requirements Management, Design Verification and Traceability.
  4. Lifecycle Risk Management.
  5. All aspects of testing including test phases Installation Verification, Operational Qualification/Verification and UAT.

Desired Qualifications:

A related third level degree or equivalent business experience.
Understanding of global regulatory requirements/guidance pertaining to Computerised Systems Validation eg US FDA 21 CFR Part 11; Electronic Records and Electronic Signatures.
Understanding of global regulatory requirements/guidance relating to Data Integrity, MHRA, US FDA, WHO.
Understanding of industry good practices e.g., ISPE GAMP Guidelines and Good Practice Guidelines.
The successful candidate must be authorised to work in the EU and be available to travel to client sites as required. The majority of the role will be remote based.

This is a fantastic opportunity to join a scaling company with outstanding long term career prospects for the successful candidate. For more information contact the Talent Partners team today.