Senior CSV Manager

Proclinical are recruiting for a Senior CSV Manager to join a pharmaceutical organisation. This role is on a permanent basis and is located in Iceland.

Responsibilities:

• Guide, handle, and evolve the CSV team.
• Monitor the validation of computerised systems which involves GxP systems such as LIMS, MES, and ERP.
• Perform risk assessments for computerised systems.
• Guarantee that all CSV actions are recorded rendering to company SOPs and regulatory needs.
• Offer CSV-linked training to team members and any other personnel.
• Contribute to audits and inspections as the CSV SME (subject matter expert).
• 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 role within a pharmaceutical or biotech organisation.
• Know-how of GxP regulations, 21 CFR Part 11, Annex 11, and any other applicable standards.
• Leadership and team management capabilities.
• 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 Patrick Turbidy at p.turbidy@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.

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