Computer System Validation Consultant - Life Science

PQE Group; Dortmund; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

PQE Group is seeking a skilled Computer System Validation Consultant to support projects in Germany, Austria, and Switzerland. In this role, you will ensure compliance and document management while collaborating with diverse teams across international projects. Ideal candidates are proficient in German and English and have a background in regulatory guidelines.

Qualifikationen

• 1 year of experience in a similar role.
• German and English full proficiency.
• Knowledge of regulations and guidelines applicable to computerized systems.

Aufgaben

• Resolve Computer System Validation compliance issues.
• Prepare project-related documents and ensure compliance.
• Maintain project and lifecycle document traceability.

Kenntnisse

Team Player

Knowledge of GAMP

Regulation Compliance

Jobbeschreibung

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas .

Following a new opportunity, we are currently looking for a Computer System Validation (CSV) Consultant to support our projects in Germany, Austria and Switzerland.

You will be responsible for :

• Resolution of fundamental Computer System Validation compliance issues on assigned projects. Writing, reviewing and executing computer validation documentation
• Ensure all project-related issues and deviations are recorded, approved and dispensed accordingly (including ensuring proper deviation report preparation and approval)
• Preparation of project and life‐cycle reports and review / approve all other documents to ensure compliance with SOP
• Ensure all project and lifecycle documents achieve the goal of traceability, and these are all retained in the document repository (Document Navigator) and approved following the prescribed SOP

About you :

• 1 year of experience in a similar role
• German full proficiency
• English full proficiency
• Availability to travel to our clients in Germany, Switzerland and Austria
• Knowledge of regulations and guidelines applicable to computerized and automated systems (GAMP, 21 CFR part 11, …)
• Ability to work as a team player in a consulting environment

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.