Computerized Systems Validation Lead

vor 2 Monaten

Lausanne, Schweiz Proclinical Vollzeit

Proclinical are recruiting a Computerised Systems Validation Lead for a pharmaceutical corporation. This role is on a permanent basis and is located in Lausanne.

**Responsibilities**:

- You will be a part of CSLC/CSV Project Teams for specific computerised systems or appoint it to a CSV qualified individual.
- Maintain oversight on DPI computerised system portfolio and plan, conduct and monitor periodic evaluation actions of computerised systems.
- Offer constant assistance by serving as the internal advisor on pertinent processes and guidelines to guarantee correct comprehension and execution of CSV.
- Guarantee oversight of allocated actions to DPI collaborators as well as review the performance of individuals as per DPI standards.
- Form cooperative and working relations as well as guarantee adequate communication in DPI cross-functional and CSV project teams and quality division.
- Other duties may be assigned to this role.

**Key Skills and Requirements**:

- Educated to an advanced degree level in a scientific, engineering or clinical field.
- At least 15+ years of experience in quality management within a pharmaceutical organisation, with at least 5 years in CSV and qualification actions.
- Familiarity with handling and performing audits.
- Know-how of GxP and connected necessary validation actions.
- Present expertise on ICH GCP E6, 21 CFR Part 11, EU Annex 11, GAMP 5, and guidance/reflection documents.
- Acquaintance with setting up and working with various teams.
- You are deliverables driven.
- Focused on efficiency, continuous improvement, and compliance.
- Able to think methodically and implement a risk-based approach.
- A high attention to detail.
- Fluency in the English language with knowledge in French.

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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