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Job Details

Computerised System Validation (CSV) Specialist - Austria (open to relocators)

Company: Planet Pharma Staffing Limited
Reference: UK_61254_AUS
Closing Date: 30 Dec 18
Type: Contract
Salary (£): Competitive

Job Summary:

Our client is a worldwide known biotechnology company that works across over 150 countries. Their main focus is in area of human and environmental health, and they are responsible for providing outsorced Lab based services in relation to research. Our client offers instruments, reagents, assay platforms, and software to hospitals, medical labs, clinicians, and medical research professionals to help improve the health of families.


* 1 year contract role *

** Fully office based near Vienna, Austria **

*** Role open to relocators ***

Main responsibilities

  • Design, Author, and Execute Computerized System Validation (CSV) – according to GAMP 5 guidance – especially on Analytical Laboratory Test Equipment and other Lab Information System
  • Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents
  • Translate technical information and requirements into qualification/validation test design

Qualification and Experience

  • Bachelor’s Degree; scientific background preferred
  • At least 2 years of pharmaceutical of FDA related validation experience
  • Good knowledge of GMPs, 21CFR Part 11, USP 1058 – and other relevant industry regulations and guidance
  • Strong interpersonal skills and demonstrated ability work independently
  • Self-directed and motivated individual who is able to operate in a rapidly changing business environment
  • Customer-oriented, conducting job function with a primary focus on customer satisfaction (internal & external) and ability to deal with customer complaints
  • Ability to Build consensus among team of stakeholders
  • Excellent critical thinking/analytical and problem solving skills

Apply for this job: Computerised System Validation (CSV) Specialist - Austria (open to relocators)

Contact Information:

Address:  Head Office
10 Greycoat Place, London,
Tel:  +44 203 868 1000
Website:  Visit Our Web Site

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