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. Your responsibilities: Release of final packed product to market, including the materials needed
Quality assurance of raw materials, packaging components and products
Review and approval of documentation for disposition decisions
Disposition decisions for media, raw materials, incoming materials, components, pre-treated components, substance and products under current qualification programs
Approval and verification of deviations, actions and CAPA investigations
Assessment of deviations, validations, qualifications and planned deviations
Review and approval of CAPA action plans, implementation and effectiveness checks
Review and approval of records and governing documents, e.g. for validation, manufacturing and trials
Review and approval of instructions for affected processes at the site
Development and improvement of quality management processes in line with division requirements
QA representation in Change Control, Risk Management and projects
Continuous 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. Requirements: At least 1 year of experience in GMP-controlled operations in the pharmaceutical industry and/or device manufacturing
Experience in medical device and/or pharmaceutical manufacturing
Experience in QA release and disposition
Experience in deviation, CAPA and investigation management
Three-year academic degree with a pharmaceutical, scientific or technical focus, or equivalent
Native Swedish and fluent English, spoken and written
GMP and quality systems expertise
Good 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 14001
Strong documentation review skills
Good IT skills
Cooperative, with the ability to work across functions
Handles stress and stressful situations well
Goal-oriented, structured and responsible
Independent and takes initiative
High integrity
Able to plan and prioritize the department's goals and your own work
Nice to have: Experience in validation and qualification
Experience in Change Control and Risk Management
Knowledge of environmental and other relevant standards
A continuous improvement mindset
Strong 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.