ppAre 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. /p pWe are seeking an experienced Pharma Compliance Support Consultant in Barcelona (Spain) to support our pharmaceutical clients in ensuring compliance with general regulatory requirements and driving continuous improvement of Quality Management Systems (QMS). /p h3Responsibilities: /h3 ul liManage, maintain, and improve Quality Management Systems (QMS) in compliance with GMP regulations and applicable regulatory requirements (EU GMP, FDA, ICH). /li liSupport clients in QMS implementation, remediation, and continuous improvement initiatives. /li liParticipate in internal audits, supplier audits, mock inspections, and regulatory inspections. /li liCoordinate and support Validation activities, define validation strategies, acceptance criteria, and sampling plans. /li liSupport Technology Transfer projects between manufacturing sites and external partners. /li liParticipate in remediation activities resulting from inspections by regulatory authorities. /li liAssist in the preparation and review of responses to regulatory observations and commitments.



/li liParticipate in Quality Risk Management initiatives, including process risk assessments and cross-contamination risk assessments. /li /ul h3First Project you will be assigned to: /h3 ul liDuration of this first project: 7 months (We offer a permanent contract) /li liOur offices are in Barcelona and Madrid /li /ul h3Requirements: /h3 ul liBachelor's Degree in a scientific discipline such as Pharmaceutical Chemistry (CTF), Pharmacy, Chemistry, Biotechnology, Biology, Microbiology, Pharmaceutical Sciences, or related fields. /li li3 years of experience in Quality Assurance, Quality Compliance, or Validation roles within the pharmaceutical industry and/or GMP consulting environments. /li liStrong knowledge of Quality Management Systems (QMS), GMP regulations, Process Validation, and Cleaning Validation. /li liHands on support for reviewing and amending procedures/SOPs on a new aseptic process. /li liScope of the process includes Compounding and Filling machinery with Isolator. /li liFDA and EU GMP knowledge is preferred and also experience in aseptic processes. /li liExperience supporting inspection readiness activities and regulatory audits. /li liNative in Spanish and fluent in English (minimum B2 level). /li /ul ul liSalary starts from 30.000€ gross per year /li /ul /p #J-18808-Ljbffr

📌 Compliance Support (Barcelona)
🏢 Pqe Group
📍 Barcelona