Stellenbeschreibung:

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 across 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:

1. Resolving fundamental Computer System Validation compliance issues on assigned projects. Writing, reviewing, and executing computer validation documentation.
2. Ensuring all project-related issues and deviations are recorded, approved, and addressed accordingly, including proper deviation report preparation and approval.
3. Preparing project and lifecycle reports, and reviewing/approving all other documents to ensure compliance with SOPs.
4. Ensuring all project and lifecycle documents achieve traceability and are retained in the document repository (Document Navigator) and approved following the prescribed SOP.

About you:

• At least 2 years of experience in a similar role.
• Full proficiency in German.
• Full proficiency in English.
• Availability to travel to clients in Germany, Switzerland, and Austria.
• Knowledge of regulations and guidelines applicable to computerized and automated systems (GAMP, 21 CFR part 11, etc.).
• Ability to work as a team player in a consulting environment.
• LIMS validation experience (nice to have).

Next Steps:

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

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

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

If the outcome is negative, we will inform you that the recruitment process has been halted.

Working at PQE Group:

As a member of PQE, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE offers opportunities to work on international projects, enhance your skills, and collaborate with colleagues worldwide.

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

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

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