Computerised System Validation (CSV) Engineer

Location
Oxfordshire
Salary
Up to €60,000
Posted
04 May 2021
Closes
03 Jun 2021
Ref
UK18478UK
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Client: Global Pharma
Type: Permanent
Location: Oxfordshire

You will provide specialized knowledge and information to guarantee the proper computerised system Life cycle from installation, to retirement ensuring the compliance with relevant regulatory requirements. (FDA 21 CFR Parts 11 and 211 and EU GMP Annexes 11 and 15 and MHRA Guidance)

Responsibilities

  • Define the CSV strategy
  • Assess the technical documents and test protocols provided by vendor/ supplier (i.e. FAT, SAT, IQ; OQ)
  • Provide support in writing/reviewing the SOP issued to manage a computer systems if necessary
  • Provide support and guidance for CS DRs and CAPA resolution
  • Assess the CS compliance to 21 CFR Part 11 Compliance and identify mitigation actions
  • Prepare all project-based documentation for computerized systems such as but not limited to Planning, Risk assessment, System Configuration Test protocols, Reporting
  • Ensure the computer systems changes are assessed, managed and documented in accordance to site procedure
  • Ensure the computer systems are periodically reviewed in accordance to site procedure.

Qualifications

  • Extensive experience in CSV.
  • Good Knowledge of GAMP5 guide and MHRA ‘GXP Data Integrity Guidance and Definitions, FDA 21 CFR Part 11, EMEA Annex 11 regulations
  • Experience with automation and manufacturing systems especially in the sterile equipment
  • Ability to multi-task, meeting tight deadlines.
  • Experience of developing and influencing business strategy is desirable
  • Experience of leading, supervising and motivating a team
  • You will be proactive in your approach and have the ability to manage your team and their workload, priorities and actively engage in their development

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