Computer Systems Validation Specialists x5

Our client has 5 open positions for Computer System Specialists (CSV Specialist). A fantastic opportunity has arisen for Computer Systems Validation (CSV) professionals to join a UK based pharmaceutical company.

JOB FUNCTIONS

- Participate in the development of strategic compliance deliverables to support applicable regulations and internal policies and to ensure systems to be developed adhere to company SDLC methodology.
- Drive understanding and adoption of Quality and Compliance standards.
- Ensure Quality & Compliance requirements are considered in any initiative or major change request.
- Ensure the compliance deliverables are updated and kept current with all applicable changes.
- Work with IT and business teams within business units to drive/maintain/create Quality program.
- Align the development methodology with Compliance plans, policies and procedures.
- Effectively manage ongoing change control process (interface to IT support, impact analysis, release mgt, data changes, testing etc.).
- Build strong relationships with quality business unit owners.

REQUIREMENTS:

- University Degree
- 4+ years Big Pharmaceutical or CRO industry experience with clinical/safety systems
- 4+ years' experience developing and implementing the validation process and validation deliverables
- Excellent understanding and experience with industry regulations, standards, and guidelines, eg, ICH, GMP, validation, 21 CFR Part 11, etc.
- Excellent interpersonal, communication, organizational, and project management skills
- Excellent presentation and writing skills Knowledge of Clinical Laboratory Process Previous Experience supporting Validation project with GxP