The plant in Halden specializes in the production and distribution of IV Drugs and Standard solutions, both for Fresenius Kabi worldwide and through product partnering. In Norway, we currently have a factory in Halden and a marketing office in Oslo, and we have just over 550 employees. Fresenius Kabi Norge AS is part of the German group Fresenius SE, with headquarters in Frankfurt, Germany. The group currently has over 300,000 employees, in more than 100 different countries around the world. For more information - See our website: Fresenius-kabi.com/no
Quality Assurance Project Manager (m/f/d)
US Supply Sites Portugal
Are you looking for an international position as a part of global leader team in manufacturing sterile pharmaceuticals? Are you a driver of change and open for new challenges? Then we have the perfect opportunity for you.
Join our Quality Management team within the Pharmaceuticals & Devices as Quality Assurance Project Manager for our production units Uppsala and Brunna in Sweden, Graz in Austria, Halden in Norway, Friedberg in Germany and Santiago de Besteiros in Portugal.
Furthermore, we are happy to offer you a working place in one of our facilities in Graz, Uppsala, Halden or Santiago de Besteiros.
- You provide current GxP support and advice to the local QA, QC and plant teams in order to close possible compliance gaps in the laboratory or production
- Together with the plants you prepare documentation for closing gaps, to maximize a knowledge transfer from the position holder to the plant staff and increase knowledge at the plant
- You also do the assessments in audit and inspection style to verify laboratories and production areas comply to GxP standards and to prepare for authority inspections
- You are responsible for additional tasks related to the overall Quality Management System, e.g. participate in global quality system harmonization groups and prepare plants for authority audits
- You also summarize and analyse quality metrics
- You recognize and track new developments in sterile manufacturing and propose quality improvement initiatives to plant management & plant QA
- You prepare or revise quality management documents
- You analyse and implement guidelines (GMP, ICH, ISO, etc.) in accordance with national and international legislation
- You are responsible for the Execution of Quality initiatives, which are started by the Competence Centers of the Pharmaceuticals & Devices Division within Fresenius Kabi
- Higher education at master's level in Pharmacy, Chemistry, Biology, Chemical engineering or other relevant education
- Several years of experience in the pharmaceutical GxP environment and proven knowledge on the requirements and application of pharmaceutical quality systems, EU GMP, WHO GMP, CFR210/211, ISO 13485 and ISO 9001 and other relevant standards
- Willingness to travel approximately 50% globally, mainly in Europe
- Experience from GMP inspections and audits is an advantage
- Broad experience in leading teams
- Ability to organize multiple tasks in several plants
- Good communication skills
- Fluent English skills - written and spoken
If you are interested to go on this journey with us, feel free to apply for this position!
Please apply in English before the 5th of March 2021.
For further information, please contact Teresa Martin, Fresenius Kabi Deutschland GmbH.