Requirements: English
Company: PQE Group
Region: Celr , Catalonia
Are you ready to join aworld leaderin the exciting and dynamic fields of thePharmaceutical and Medical Device industries? PQE Grouphas been at the forefront of these industriessince 1998, with40 subsidiariesand more than2000 employees in Europe, Asia and the Americas.We are currently seeking a dedicated and detail-orientedGMP Compliance Qualification Engineerto support theEngineering and Maintenance departmentin ensuringstrict adherence to GMP regulations. The role involves overseeingqualification activities ,managing quality documentation, supportingtechnical change controls, and ensuringdata integrityin line with current regulatory expectations.Please note:Although the primary location for this role isBarcelona, for approximately thefirst 6 monthsthe selected candidate will be required to work100% on-site in Celr (Girona province).Responsibilities include, but are not limited to:Manage GMP requirementsapplicable to the Engineering and Maintenance department.Conduct investigationsrelated toincidents, deviations, OOS, and manage the associatedCAPAs .Prepare, evaluate, implement, and follow up onQuality Risk Assessments (QRA)for both new and existing facilities.Leadcommissioning and qualificationprocesses for new installations.Liaise withvendorsand reviewdocumentationto execute qualification tests.Develop and maintain the annual qualification plan .Draft and manageUser Requirement Specifications (URS)andqualification protocols .Execute qualification documentationand ensure compliance throughout the lifecycle.Manage and executeTechnical Change Controls .Ensure properfacility designaligned with all applicableGMP requirements .Support the Maintenance team indocumentation management .Implement and ensure compliance withdata integrityandcomputerized systems validation (CSV)requirements.Execute additional tasks as assigned by theEngineering department .Required Qualifications:Bachelor's degreein Engineering, Life Sciences, or related field.Strong knowledge ofGMP regulationsandpharmaceutical engineering practices .Experience inequipment qualification ,validation, andtechnical documentation .Familiarity withdata integrity requirementsandcomputerized system validation (CSV) .Analytical mindsetandattention to detail .Ability to workcross-functionallyand communicate effectively withvendorsandinternal stakeholders .Fluency inEnglish and Spanishis required.Next StepsUpon 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 GroupAs a member of the PQE team, you will be part of achallenging, 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.