QA Support Technician
il y a 1 jour
Celrà
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. We are currently seeking a QA Support Technician will be part of the Quality Assurance Department and will ensure GMP compliance of qualification activities related to equipment, facilities, and plant utilities within a pharmaceutical environment. Responsibilities include, but are not limited to: • Act as Quality Assurance approver for initial qualification protocols and reports (IQ/OQ/PQ)., • Review and approve requalification protocols and reports for: HVAC systems, Nitrogen systems, • Compressed air systems and Warehouse temperature mapping, • Ensure qualification documentation complies with GMP requirements and internal procedures., • Review and approve investigations and CAPA plans related to deviations involving equipment and facilities., • Monitor CAPA implementation and ensure timely closure., • Assess CAPA effectiveness prior to final closure., • Provide QA oversight of modification activities performed by Engineering., • Review and approve qualification plans for associated equipment., • Evaluate and approve change controls related to equipment and facilities, ensuring proper GMP and regulatory impact assessment., • Collaborate cross-functionally with Engineering, Production, and other relevant departments. Required Qualifications: • Degree in Chemical Engineering or similar technical/scientific field., • Experience in a GMP-regulated pharmaceutical environment., • Proven background in equipment, facilities, and utilities qualification (IQ/OQ/PQ)., • Experience in deviation management, CAPA, and change control., • Solid knowledge of GMP regulations, HVAC systems, and plant utilities., • Strong analytical skills, attention to detail, and ability to work cross-functionally. 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 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 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.
