Qualified Person Sweden/Manager regulatory affairs and quality
World leader in gases, technologies and services for Industry and Health, Air Liquide is present in 80 countries with more than 68,000 employees and serves more than 3 million customers and patients. Oxygen, nitrogen and hydrogen have been at the core of the company’s activities since its creation in 1902. Air Liquide’s ambition is to be the leader in its industry, delivering long-term performance and acting responsibly.
Entity and activity description
Air Liquide Nordic is part of the Air Liquide Group. We form a joint Nordic organization with 500 employees working from more than 50 sites. Our success is built on the competences and performance of our employees. Air Liquide Nordic has a Healthcare division covering Sweden, Denmark and Norway.
We offer good development opportunities, e.g. through our career programs for both managers and experts, and there is a possibility of making a career, both internationally and nationally. We have a culture that encourages innovation and independent initiatives, and we offer a safe and diverse working environment with a good work-life balance.
About the position
This is a permanent, full-time QP and manager regulatory affairs/quality position and it is placed in Malmö. It includes work also in Norway and Denmark. You need to be fully qualified as a QP.
You will lead a team of one QP in Sweden/Norway, one QP in Denmark, and two more resources placed in Denmark You will report to the Healthcare director. You need to be able to travel around 20-30 days a year, in DK, NO and SE.
Missions and Responsibilities
The position will have its focus on managing the team, regulatory affairs and GMP/GDP. There will also be some parts of MDD and PV.
- QP, responsibilities according to GMP Annex 16
- Regulatory Affairs
- Control and approval of batch documentation
- Participate in relevant inspections
- Lead or participate in internal audits and supplier audits
- Author for Product Quality Reviews
- Quality system incl claims, deviations, CC, procedures .
- Serve as Local Deputy Pharmacovigilance for Sweden
- Serve as Validation support in Denmark
It is a plus if you have knowledge about validation, pharmacovigilance, gas manufacturing, and/or MDD.
Competencies and Profile
- management experience
- fully qualified and experienced as a QP
- regulatory affairs
- experience as internal auditor and supplier auditor
- speaks and writes Swedish and English fluently
- driving licence
We are looking for someone who works in a structured way and takes responsibility. One of your strengths is communication, both verbal and in writing. You will work across many different functions, including industrial functions, and need also to work independently. It is important to cooperate and seek solutions. You enjoy working in an informal way in the team and near the manufacturing staff.
Questions regarding the position is answered by:
Ulrica Åhman QP
Phone: +46 40 38 11 38 / +46 72 72 60 448
Interested in the position?
Apply using the Link below latest Friday the 12th of May. We would like to have your application as soon as possible, as we will assess the applications as soon as we receive them. When we find a suitable applicant the position will be closed.