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Qa engineering specialist

Basel
PM Group
Inserat online seit: Veröffentlicht vor 7 Std.
Beschreibung

BOverview /bbr/br/pPM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and environmental sectors. /ppbWho Are We /b /ppPM Group is an employee owned, international project delivery firm. We are world leaders in the pharma, food, medtech and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our people, our clients and trade partners. /pppbAbout the role /b /p /ppQuality Engineering within the broader QA/RA function plays a key role in ensuring GMP compliance across production, analytical, and infrastructure systems, while supporting the continued growth and innovation of PM Group’s Life Sciences portfolio. To reinforce our high-performing team, we are currently seeking a motivated and technically strong QA Engineering Specialist (m/f/d). /p br/b Responsibilities /bbr/br/ppbResponsibilities: /b /p /ppAs a member of the QA Engineering team, you will play a central role in the lifecycle management of our GMP-relevant facilities and systems: /plipEnsure GMP-compliant operation of facilities throughout their entire lifecycle, including requalification, maintenance, change control, and deviation management /p /lilipContribute to qualification and validation projects (equipment, infrastructure, processes) and provide QA expert evaluation /p /lilipCreate, review, and approve GMP-relevant documents (e.g., URS, qualification packages, SOPs, logbooks) /p /lilipActively report and provide expert advice to stakeholders on technical and quality-related issues /p /lilipSupport regulatory authority inspections and customer audits, and coordinate time-critical activities such as PQR creation or batch document review /p /lilipLead smaller projects within QE and contribute to the further development of cross-functional quality processes /p /li br/b Qualifications /bbr/br/pbQualifications: /b /ppYou work precisely, proactively, and responsibly – and you have the skills to succeed in a demanding GMP environment: /plipCompleted bachelor's degree (BSc in Chemistry, Pharmacy, Process Engineering, or comparable field) or equivalent qualification with several years of QA experience /p /lilipAt least 5 years of professional experience in a GMP-regulated environment, ideally in qualification/validation or technical QA processes /p /lilipSolid GMP knowledge of Switzerland and EU, and confident creation and evaluation of GMP-relevant documents /p /lilipProficient use of MS Office, ERP/MES/QM systems, and digital communication and planning tools /p /lilipAnalytical and structured working style, high solution orientation, strong communication skills, and professional collaboration with internal and external stakeholder's /p /lilipFluent German skills /p /li

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