Computer Systems Validation Specialists x5

Berkshire  ‐ Onsite
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Keywords

Description

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
Start date
Immediate
Duration
12 months
From
Agile Strategic Consulting
Published at
04.01.2013
Project ID:
467522
Contract type
Freelance
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