Qualified Person
Air Liquide · Malmö
How will you CONTRIBUTE and GROW?
Are you ready to ensure that life-saving medical gases meet the highest standards of safety and quality for patients who rely on them?At Air Liquide, we believe that clinical excellence drives business growth, and our commitment to patient care begins with the rigorous standards we maintain in our production and distribution. We are looking for a dedicated professional to take ownership of our regulatory compliance and product release processes, bridging operational precision with patient safety.
By joining our passionate and innovative team, you will play a vital role in protecting our commitment to healthcare excellence. You will not only empower our operational sites to maintain flawless quality but also help shape the future of our regulatory strategy across the Nordic region.
Location and Scope
Based in Malmö, Sweden, you will oversee medical gas production across Sweden and serve as the Responsible Person for storage hubs in Norway. Field travel is expected approximately every second month, requiring a car to reach essential filling stations and air separation units.
What You Will Do
- Drive Clinical Quality and Product Release: Ensure the highest clinical standards by controlling and approving batch documentation for medicinal and medical products, ensuring release in full compliance with Marketing Authorizations (MA). You will conduct daily releases for filling stations and air separation units, and manage weekend release duties on a rotational basis.
- Lead Regulatory Strategy and Inspections: Serve as the primary contact person and official representative for the Swedish Medical Products Agency (Läkemedelsverket) and Norwegian regulatory authorities. You will lead regulatory inspections, manage CAPA implementation, draft response actions, and participate in Nordic meetings to shape regulatory affairs and Pharmacovigilance (PV).
- Champion Quality Management Systems (QMS): Plan, lead, and execute internal audits and supplier audits. You will evaluate and approve internal deviations and Management of Change (MOC) proposals, assess customer quality claims, lead the annual Product Quality Review (PQR), and author or update Standard Operating Procedures (SOPs).
- Empower Operational Sites and Compliance: Provide hands-on guidance for Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) across all facilities. You will conduct critical internal training sessions, support qualification and validation activities, and act as the Responsible Person with full scope for operations in Norway. Act as Delegated Qualified Person (QP) for operations in Denmark.
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Are you a MATCH?
Must Have:
- Master’s degree in Pharmacy, Chemistry, Microbiology, or a related scientific discipline.
- At least 3 years of hands-on experience working within a Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) regulated environment.
- Proficiency in English and fluency in one of the Nordic languages, with a preference for Swedish.
- A valid driver's license to facilitate travel to operational sites.
- Readiness for a phone availability expectation to satisfy strict regulatory requirements (contact occurrences are rare), alongside scheduled rotational weekend duties.
Good to Have:
- A professional background specifically as a Pharmacist is highly preferred to align with European directives.
- Strong working knowledge of Swedish medical legislation and regulatory authority expectations.
- Interest and experience in handling Regulatory Affairs tasks, such as Marketing Authorizations.
Who You Are
You are a meticulous, patient-centered professional who thrives in a highly regulated environment where precision matters. Your strong communication skills allow you to seamlessly translate complex regulatory requirements into actionable steps for operational teams. You are adaptable, structured, and resilient, capable of making critical release decisions while keeping the broader business strategy and patient well-being at the heart of everything you do.
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Our Differences make our Performance
At Air Liquide, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world.
We welcome and consider applications from all qualified applicants, regardless of their background. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world.