CSV & Quality Specialist

vor 3 Wochen

City of Melbourne, Österreich PQE Group Vollzeit

Get AI-powered advice on this job and more exclusive features. 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 our continuous growth, PQE Group is seeking an experienced CSV & Quality Specialist to support validation and quality oversight activities for a large automation and digital systems upgrade within a GMP manufacturing environment. While the role includes elements of Quality Assurance, the primary focus will be on Computer System Validation (CSV) across various project phases. The position will also provide support to selected activities in an additional systems implementation workstream. Responsibilities Lead and support Computer System Validation activities for a major automation and digital systems upgrade within a GMP environment. Review and approve validation documentation, including URS, risk assessments, validation plans, test protocols, traceability matrices, and reports. Support and participate in qualification activities such as FAT, SAT, IQ, OQ, and PQ. Ensure compliance with GxP expectations and data integrity principles. Provide technical guidance on system lifecycle management and validation strategy. Offer QA oversight for system-related documentation, change controls, deviations, and project deliverables. Support audit readiness and ensure project activities adhere to quality and compliance requirements. Collaborate with cross-functional teams to ensure timely and compliant execution of CSV and QA activities. Required Qualifications Degree in Engineering, Life Sciences, Computer Science, or a related discipline. Demonstrated experience in Computer System Validation within a GMP-regulated environment. Solid understanding of QA processes and GxP regulations. Experience supporting complex system implementation or digital transformation projects.Strong analytical, documentation, and communication skills. 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 from the Hiring Manager interview, the 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. #J-18808-Ljbffr

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