CSV Manager - Nordics
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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.
- 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 email@example.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.