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Senior CSV Specialist

Harris Lord Recruitment
Job LocationBraintree
EducationNot Mentioned
Salary£43,000 - £52,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Senior CSV SpecialistOur client, within the biotechnology field, are seeking an experienced CSV Specialist to oversee all aspects of the computer system validation programme. You will be responsible for authoring/ executing/ reporting technical validation activities within GMP framework.Key Accountabilities:

  • Drive to completion validation activities and comply with Data Integrity expectations.
  • Work with validation contractors to support commissioning and start-up activities ensuring vendors have been QA assessed.
  • Maintain up-to-date industry best practice knowledge of validation trends
  • Ensure all activities on site comply with current or proposed standards and regulatory compliance requirements
  • Supervise validation exercises performed by third parties to ensure work is completed following Data Integrity requirements
  • Work with vendors to resolve issues and ensure complete deviation reporting investigation and closure for validation activities
    • Experience:
  • BS or MS degree in life science / engineering /Computer Science
  • Broad knowledge of the commissioning and qualification of computerised systems in a regulated environment
  • Experience with cloud-based systems (e.g. SAP, Q-Pulse)
  • Experience with Control systems (dedicated integrated controllers, distributed control systems, PLCs, SCADA, Server based systems)
  • Ideally familiarity with the following requirements:
    • - Eudralex Vol.4 Annex 11, 15- FDA 21 CFR Part 11 (Electronic signatures)- MHRA GXP’ Data Integrity Guidance- ASTM E2500- GAMP 5
  • Strong leader with excellent people skills
    • Harris Lord is acting as a Recruitment Agency in respect to this vacancy.We regret that due to high volumes we are unable to acknowledge every application. All successful candidates will be contacted as soon as possible to discuss the role and their experience further Required skills
  • Computerised
  • Control Systems
  • GMP
  • Validation

    • Keyskills :
    Computerised Control Systems GMP Validation

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