Computer Systems Validation Specialists x5

Job type:
on-site
Start:
Immediate
Duration:
12 months
From:
Agile Strategic Consulting
Place:
Berkshire
Date:
01/04/2013
Country:
flag_no United Kingdom
project ID:
467522

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This project is archived and not active any more.
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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