We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998. With more than 2000 employees, 45+ nationalities and 40 subsidiaries all over the world (Europe, Asia and the Americas), joining PQE means join a multicultural and challenging company with many local and international projects, and colleagues from all over the world.
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: Bachelor’s or Master’s degree in Pharmaceutical/Industrial disciplines (Pharmacy, Chemistry, Biology, Engineering, Computer Science, etc.).
* Experience: At least 2 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
Our collaborators are engaged, developed, challenged and well-rewarded for performance.We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.
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.