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.