Overview
Quality Assurance Lead Jobs in Greater Stockholm Metropolitan Area at CLEEVEN Sc – Sweden
Title: Quality Assurance Lead
Company: CLEEVEN Sc – Sweden
Location: Greater Stockholm Metropolitan Area
QA Specialist – Sterile Manufacturing | Cleeven
Cleeven is growing within life science and is looking for an experienced QA Specialist with a background in sterile manufacturing. With us, you'll work on high-impact assignments at leading pharmaceutical companies where your expertise genuinely matters.
About Cleeven
We are a specialist consulting firm with life science as one of our focus industries. Our consultants work with leading pharmaceutical companies across Sweden and Europe — in environments where precision, documentation, and quality are non-negotiable. We believe in long-term relationships, the right match, and making sure you thrive both at the client and with us.
The Role
As a QA Specialist at Cleeven, you'll work in production-close QA roles within sterile manufacturing. You'll operate in aseptic environments involving isolator filling, device packaging, and assembly — collaborating closely with process engineers, validation engineers, and production teams. You'll drive qualification work independently, contribute to change control and risk assessments, and be the person who asks the right questions — even when the answers are uncomfortable.
Your Responsibilities
- Execute and review qualifications (IQ/OQ/PQ) of equipment and packaging lines
- Assess and contribute to Change Control (CC) processes
- Perform and review risk assessments
- Review protocols and challenge assessments where needed
- Take initiative based on input from process engineers and QA colleagues
What We're Looking For
- 3–5 years of experience in QA within the pharmaceutical industry
- At least 2–3 years with a focus on qualification and validation
- Proven experience in sterile manufacturing in an aseptic environment
- Strong GMP foundation and understanding of how it applies in production
- Experience with Change Control and risk assessment methodologies
- Ability to work independently, take initiative, and push back when needed
- Professional proficiency in Swedish and English.
This Is the Right Move for You If You
- Want variety and growth through assignments across different client environments
- Thrive in a fast-paced setting with clear expectations and deliverables
- Are looking for an employer who understands your industry and values your specialist expertise
Apply by easy apply here on Linkedin, only a resume is needed!
