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Computerized Systems Validation (CSV) Lead
- Permanent
- Switzerland
- Information Technology
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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