Computer System Validation (CSV) Technician - Cheshire - Pharma/Medical Devices

Posted 20 October by Bosch Global Associates Ltd
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Computer System Validation (CSV) Technician - Cheshire - Pharma/Medical Devices

Type: 12 month fixed term contract

Salary: Negotiable Depending on Experience

Location: North West, Cheshire Area

We are currently recruiting for a CSV Technician for our blue-chip pharma & medical client. The individual will join the Microbiology team on a 12 month fixed term contract.

Key Responsibilities:

  • Generation of computer validation documents (e.g. CSV Assessments, Val Plan, Functional Design Specification, IQ, OQ, ERES, DRP)
  • Remediation of computer systems
  • Periodic reviews of computer systems
  • Instrumentation - to manage and maintain all QC lab instrumentation
  • Demonstrate Knowledge of GAMP
  • Demonstrate knowledge of Data Integrity
  • Act as the CSV lead for Micro Laboratory projects
  • Annual Product Review - assist with compilation of product review reports in accordance with company procedure RFT, OTIF

Qualifications

  • Degree in any science related subject

Knowledge, Skills and Abilities

  • Experience working as a CSV Engineer/Technician within the Pharmaceutical/Biotechnology/Food industry
  • Able to provide coaching and training where required in CSV
  • Competence in laboratory operations
  • High degree of regulatory understanding and implementation
  • Able to collaboratively within a team
  • Attention to detail
  • Excellent communication skills - written and verbal

CSV / COMPUTER SYSTEM VALIDATION / LABORATORY OPERATIONS / Software / System Analyst/ PHARMA / PHARMACEUTICALS / GMP / MANUFACTURING / PROTOTYPE / MANUFACTURING / PRODUCTION / REGUALTORY / CLINICAL / COMPLIANCE / CHESHIRE / CHESTER / DERBY / DERBYSHIRE / MANCHESTER / LANCASHIRE / LANCASTER / LIVERPOOL / NORTH WALES / UK / UNITED KINGDOM / GSK / GLAXO / BESPAK / ASTRA ZENECA / NOVARTIS / QAIGEN / PFIZER / SANOFI BIOMEDICAL / MEDICAL / HEALTHCARE / REGULATORY AFFAIRS / QA / QUALITY ASSURANCE / FORMULATION / AUDITING

Required skills

  • IQ
  • Validation
  • CSV

Reference: 40797462

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