Csv Project Manager

buscojobs España; Burgos; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

PQE Group is seeking a CSV Project Manager in Barcelona, Spain. The role involves managing Computer System Validation projects, ensuring compliance with GxP regulations, and collaborating with cross-functional teams. Candidates should have a degree in relevant fields and at least 5 years of experience in the pharmaceutical sector.

Formación

• Minimum of 5 years in the Pharmaceutical sector.
• Fluent in Spanish and English (at least B2 level).
• Experience managing validation protocols and risk assessments.

Responsabilidades

• Lead and execute Computer System Validation (CSV) projects.
• Create and implement validation strategies and protocols.
• Conduct risk assessments and provide regulatory consulting.

Conocimientos

Regulatory knowledge

Technical skills

Risk assessment

Cross-functional collaboration

Educación

Bachelor’s or Master’s in Pharmaceutical or Industrial disciplines

Herramientas

Validation software

Test management tools

Descripción del empleo

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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.

Due to continuous growth, we are seeking a CSV Project Manager to join our team in Barcelona, Spain.

Responsibilities include, but are not limited to:

• Management of Computer System Validation (CSV) projects: Leading and executing CSV projects, ensuring compliance with GxP regulations, 21 CFR Part 11, and other relevant standards.
• 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 project success.
• Training and mentoring: Training and supporting junior consultants and client personnel on CSV principles and practices.

Requirements:

• Degree: Bachelor’s or Master’s in Pharmaceutical or Industrial disciplines (Pharmacy, Chemistry, Biology, Engineering, Computer Science, etc.).
• Experience: Minimum of 5 years in the Pharmaceutical sector.
• Regulatory knowledge: In-depth understanding of GxP regulations, 21 CFR Part 11, EU Annex 11, EU GMP, and other relevant guidelines.
• Languages: 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 managing validation protocols, reports, and risk assessments.

Location: Barcelona, Spain

Next Steps:

Upon receiving your application, if selected, the Recruiting department will contact you for an initial HR interview. If successful, a technical interview with the Hiring Manager will follow. A positive outcome from this interview will lead to further steps or a proposal discussion. If not selected, we will inform you accordingly.

Working at PQE Group:

As part of PQE, you'll join a challenging, multicultural company that values collaboration and innovation. PQE offers opportunities to work on international projects, improve your skills, and collaborate with colleagues worldwide.

If you seek a rewarding and exciting career, PQE Group is the ideal place for you.

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

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