CSV Manager - Nordics

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