CSV Manager - Nordics

Up to €1 per annum
  1. Permanent
  2. Validation
  3. Iceland
Höfuðborgarsvæði, Ísland
Posting date: 09 Jan 2024
58179

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting for a CSV Manager - Nordics to join a biotech organisation. This role is on a permanent basis and is located in the Nordics.

Responsibilities:

  • Guide, handle, and develop the CSV team.
  • Monitor the validation of computerised systems which involves GxP systems such as LIMS, MES, and ERP.
  • Execute risk mitigation methods for CSV actions.
  • Guarantee that all actions are documented rendering to the company's SOPs and regulatory needs.
  • Offer CSV-connected training to team members and any other personnel.
  • Collaborate with IT, quality assurance and any other divisions to assure integrated system compliance.
  • Other duties may be assigned.

Key Skills and Requirements:

  • Educated to a degree level in a computer science, engineering or similar field, though an advanced degree would be ideal.
  • Demonstrable experience in a computer system validation within a pharmaceutical or biotech setting.
  • Know-how of GxP guidelines, 21 CFR Part 11, Annex 11 and any other pertinent standards.
  • Leadership abilities with the capacity to manage own time efficiently.
  • Interpersonal and communication skills both verbally and in writing.
  • An organised individual.

If you are having difficulty in applying or if you have any questions, please contact Dominic Williams at d.williams@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#Engineering

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