Vacant job

Are you an experienced Quality Assurance Specialist? Jefferson Wells is now seeking a QA Validation Lead for an exciting consulting assignment in Uppsala. In this role, you will have overall responsibility for planning, driving, and following up validation activities in projects according to applicable regulatory requirements. Do you want to develop your career in quality assurance, GMP, and ISO 13485 with us at Jefferson Wells? Then this assignment is for you - start as soon as possible!

Location: Uppsala
Start: As soon as possible (no notice period)
Assignment length: Initially 1.5 years
Employment: Consultant employed by Jefferson Wells, assignment at a client within the pharmaceutical industry
Other: Possibility for remote work by agreement, but the majority of the work will be on-site in Uppsala

About the job as a Quality Assurance Specialist

As a QA Validation Lead at Jefferson Wells, placed at our client within the pharmaceutical industry, you will play a key role in the validation work of projects. You are responsible for ensuring that all validation activities are planned, executed, and documented according to GMP and ISO 13485. The role involves close collaboration with cross-functional teams and requires both strategic and operational work.

Examples of tasks:

• Lead and drive validation activities in projects.
• Define validation scope and develop validation plans.
• Ensure that validation activities meet regulatory requirements.
• Establish and approve validation reports and strategies for (re)validation.
• Perform risk assessments to determine the scope of validation.
• Review and approve documentation such as URS, IQ/OQ/PQ, and validation reports.
• Ensure requirement traceability and testability throughout the process.

The candidate we are looking for

We are looking for someone with solid experience in validation within the pharmaceutical industry or medical devices who enjoys taking a leading role in projects. You are structured, analytical, and quality-conscious with the ability to drive validation activities both operationally and strategically. You are accustomed to cross-functional collaboration and communicate fluently in both Swedish and English.

Requirements:

• At least 3-5 years of experience in validation within pharma/medical devices.
• At least 3-5 years of experience with GMP and/or ISO 13485:2016.
• Practical experience with Commissioning, IQ/OQ/PQ, URS, and validation plans.
• Technical experience in equipment qualification within pharma/medical devices.
• Experience with good documentation practices.
• Fluent in Swedish and English, both spoken and written.
• Available to start immediately (no notice period).

About Jefferson Wells
Jefferson Wells is a consulting and recruitment company specializing in the supply of managers and specialists. Jefferson Wells' unique expertise and industry experience enable us to help businesses grow and offer long-term career development for our candidates. Jefferson Wells operates in about 50 locations in Sweden and in more than 50 countries worldwide and is part of ManpowerGroup. With our extensive network, we can offer a multitude of exciting job opportunities. We match your skills and career goals with some of Sweden's most attractive businesses and brands, allowing you to achieve your career objectives.

Application

We warmly welcome your application by registering your CV. Please note that we do not accept applications via email. Selection is ongoing.