Requirements: English
Company: PQE Group
Region: catalonia, spain , Catalonia
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.
Due to a constant growth, we are looking for a CSV Project Manager to join our team in Barcelona, Spain.
Responsibilities include, but are not limited, to the following:
- Management of Computer System Validation (CSV) projects: Leading and executing CSV projects, ensuring compliance with GxP regulations, 21 CFR Part 11, and other relevant regulations
- Development of CSV strategies and protocols: Creating and implementing strategies, plans, and validation protocols (IQ/OQ/PQ) for laboratory, manufacturing, and enterprise application computer systems.
- Risk assessment and mitigation: Conducting risk assessments and developing mitigation strategies for computer systems.
- Conducting validation activities: Reviewing documentation, performing tests, and managing deviations during validation activities.
- Regulatory consulting in the CSV field: Providing expert advice on regulatory requirements and industry best practices for computer system validation.
- Cross-functional collaboration: Working closely with IT, Quality Assurance, and Regulatory Affairs teams to ensure the success of projects.
- Training and mentoring: Training and supporting junior consultants and client personnel on CSV principles and practices.
Requirements:
- Degree: Bachelors or Masters degree in Pharmaceutical/Industrial disciplines (Pharmacy, Chemistry, Biology, Engineering, Computer Science, etc.).
- Experience: At least 5 years in the Pharmaceutical sector.
- Regulatory knowledge: In-depth knowledge of GxP regulations, 21 CFR Part 11, EU Annex 11, EU GMP, and other relevant guidelines.
- English language: Fluent written and spoken Spanish and English (at least B2 level)
- Technical skills: Familiarity with key validation software, test management tools, and computer systems.
- Technical documentation: Experience in managing technical documentation (validation protocols, reports, risk assessments).
Location: Barcelona, Spain
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.