QA Release Specialist

We at WeQuel are now looking for a QA Release Specialist in Uppsala, where you will be a key part of the client's Quality Assurance function, with a focus on releasing final packed product to market and making disposition decisions. You will quality assure deviations and CAPA, and help develop and improve quality management processes so they meet the requirements of the client's division.

As a consultant with us, you will get the opportunity to work at one of our clients, leading companies in the pharmaceutical and medical device industries. There you will help ensure product quality and regulatory compliance, strengthen quality management processes and support continuous improvement.

Release of final packed product to market, including the materials neededQuality assurance of raw materials, packaging components and productsReview and approval of documentation for disposition decisionsDisposition decisions for media, raw materials, incoming materials, components, pre-treated components, substance and products under current qualification programsApproval and verification of deviations, actions and CAPA investigationsAssessment of deviations, validations, qualifications and planned deviationsReview and approval of CAPA action plans, implementation and effectiveness checksReview and approval of records and governing documents, e.g. for validation, manufacturing and trialsReview and approval of instructions for affected processes at the siteDevelopment and improvement of quality management processes in line with division requirementsQA representation in Change Control, Risk Management and projectsContinuous improvement of the quality management system

You will work in a regulated, fast-paced environment. You plan and prioritize your own work and the department's goals, and you work closely with other departments with a holistic view.

At least 1 year of experience in GMP-controlled operations in the pharmaceutical industry and/or device manufacturingExperience in medical device and/or pharmaceutical manufacturingExperience in QA release and dispositionExperience in deviation, CAPA and investigation managementThree-year academic degree with a pharmaceutical, scientific or technical focus, or equivalentNative Swedish and fluent English, spoken and writtenGMP and quality systems expertiseGood knowledge of GMP/ISO regulations and guidance, including EU GMP, 21 CFR Part 820, Part 210/211 and Part 11, ICH Q1, ISO 13485 and ISO 14001Strong documentation review skillsGood IT skillsCooperative, with the ability to work across functionsHandles stress and stressful situations wellGoal-oriented, structured and responsibleIndependent and takes initiativeHigh integrityAble to plan and prioritize the department's goals and your own work

Experience in validation and qualificationExperience in Change Control and Risk ManagementKnowledge of environmental and other relevant standardsA continuous improvement mindsetStrong soft skills

Assignment details

Start: [to be confirmed]End: [to be confirmed]Workload: 100%Location: Uppsala, 100% ONSITE

We offer

At WeQuel, you become part of a consultant team that puts people first. We believe success comes from engagement, collaboration and development. We offer a flat organization with short decision paths, a strong sense of community, and the chance to shape your own development.