Senior CSV Manager job in Höfuðborgarsvæði, Ísland

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First Name*

Last Name*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Validation

Location: Iceland

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

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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