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Lead CSV Engineer

Central Employment Agency (North East) Limited
Job LocationMiddlesbrough
EducationNot Mentioned
Salary£60,000 - £65,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Central Employment are thrilled to be working with a leading pharmaceutical business based in the North East of England. Due to extensive growth, Im looking for Lead CSV Engineer in a permanent capacity. This is a senior opportunity that will suit those with extensive CSV experience from automation preferably within pharmaceuticals. You will be instrumental in the CSV process and will act as a subject matter expert for the business. GAMP 5 knowledge is essential for this role.This is a permanent role with sponsorship available Key Responsibilities

  • Ensure all computerised systems are validated correctly
  • Provide project teams with expert computerised system validation guidance and definition of appropriate CSV strategies
  • Preparation and review of all levels of validation documents including Validation Plans, User Requirement Specifications, Design Specifications and SOPs
  • Qualification Documents (DQ, IQ, OQ, PQ, FATS/SATS
  • Provide training on Computerised System Policies including industry regulation trends
  • Audit as CSV subject matter expert, suppliers of computerised systems or external partners
    • Essential Requirements
  • At least 5 years experience of GAMP, risk-based approach to validation
  • Knowledge of data management and data integrity needs within a GMP regulated environment
  • Demonstrable project work on automated systems CSV requirements
  • Carried out supplier audits as Subject Matter Expert within CSV
  • Defined validation strategies for system upgrades and new system implementations
    • The Person
  • Self-motivated, flexible and able to work under pressure
  • Excellent management, documentation and communication skills
  • Strategic thinking, concern for standards ability to empower and influence
    • This is a fantastic opportunity to join a global business going through a significant period of change. Required skills
  • Automation
  • GMP
  • CSV
  • Data Validation
  • GAMP

    • Keyskills :
    Automation GMP CSV Data Validation GAMP

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