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Job Details

CSV Engineer – Freelance – Belgium

Company: MSI Group Limited
Location:
Reference: VRCSV 9092
Closing Date: 13 Mar 18
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

CSV Engineer – Freelance – Belgium MSI Pharma are currently sourcing a Tri- lingual (FR/DE/UK) CSV engineer for a global pharma company based in Belgium for a 6 month assignment. This role will be part of a larger program of work and will be working with one of the manufacturing sites in Germany to support CSV activities

Requirements:

CSV Engineer – Freelance – Belgium

MSI Pharma are currently sourcing a Tri- lingual (FR/DE/UK) CSV engineer for a global pharma company based in Belgium for a 6 month assignment. This role will be part of a larger program of work and will be working with one of the manufacturing sites in Germany to support CSV activities

Role overview;

  • Writing, reviewing and approving of validation plans and validation summary reports
  • Reviewing and approving of Technical Change Description
  • Reviewing and approving of IQOQ protocols & reports, PQ protocols & reports
  • Reviewing of CVS specific SOP’S and Templates
  • Ensure the proper execution of the qualification and validation activities with respect of the validation methodology

Experience requirements

Knowledge of:

  • CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …)
  • Validation practices and guidelines (life cycle approach, ICH, ASTM E2500

Education:

  • University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
  • Certification in computer system validation or equivalent is a plus.

Experience;

  • At least 3 years experience in a computer systems validation role

Minimum Languages;

  • English – Fluent
  • French – Intermediate
  • Germany- Intermediate

 

Apply for this job: CSV Engineer – Freelance – Belgium

Contact Information:

Address:  Head Office
3rd Floor East, Cottons Centre, 47/49 Hays Lane London SE1 2QE
SE1 1QL
England
Tel:  02079401985
Fax:  02079909763
Website:  Visit Our Web Site

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