Computerized Systems Validation (CSV) Lead

Proclinical are recruiting a Computerized Systems Validation (CSV) Lead for a pharmaceutical organisation. This role is on a permanent basis and is located in Lausanne.

Responsibilities:

• Supervise maintenance and assistance actions following system execution.
• Uphold an overview of the company's computerised systems portfolio and perform periodic evaluation.
• Serve as an internal advisor on pertinent processes and guidelines, assisting with correct comprehension and execution of CSV.
• You will get involved in CSLSC/CSV project teams or allocate tasks to qualified individuals.
• Offer direction on the CSV approach ad guarantee the constant implementation of the predefined strategy.
• Work alongside cross-functionally to develop, evaluate and approve CSV deliverables.
• The ideal candidate will verify accomplished verification actions and test defects, all while also handling risk and mitigation procedures.
• Responsible for co-approving change control records before and after system execution.
• Guarantee efficient delegation of tasks and review individual performance based on company standards.
• Other duties may be assigned to this role.

Key Skills and Requirements:

• Educated to an MS degree level in a scientific, engineering, or clinical discipline.
• At least 15+ years of experience in quality management in a pharmaceutical organisation with at least 5 of those years dedicated to CSC and qualification actions.
• Familiarity in performing audits and handling audit procedures.
• Know-how of GxP and the affiliated validation actions, which involves familiarity with ICH GCP E6, 21 CFR Part 11, EU Annex 11, GAMP 5, and any pertinent guidance documents.
• Works well with others.
• A results focused attitude oriented around effectiveness, constant improvement and compliance.
• Able to think tactically as well as implement a risk-based approach to making decisions.
• Fluency in the English language with knowledge in French would be advantageous.

If you are having difficulty in applying or if you have any questions, please contact Sheridon Lloyd on +41 61 563 1243.

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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