Quality Assurance Officer - Manufacturing Site (M/F/X)
About the company
About ALK A global leader in allergenic immunotherapy (AIT), ALK is a Danish pharmaceutical company committed for over 100 years to the prevention, diagnosis, and treatment of severe respiratory allergies. Present in 47 countries, the Group employs nearly 2,800 people. The French subsidiary, one of the Group's main subsidiaries, is located in La Défense, Varennes-en-Argonne, and Vandeuil.
Your tasks
Your Role As part of a fixed-term replacement contract, you will join the Quality Assurance team of our manufacturing site and work in close collaboration with our Manufacturing Site Quality Assurance Manager.
In alignment with parent company requirements, Management's quality commitments, and applicable legislation, you will contribute to the implementation and monitoring of the quality system. You will also participate in the validation of the manufacturing site's computerized systems and their maintenance in a validated state.
This position offers an opportunity to contribute concretely to compliance with quality and regulatory requirements, while providing operational support to the Quality Assurance Manager in their various activities.
RESPONSIBILITIES AND ACTIVITIES
- Ensure the monitoring of computer validation for the manufacturing site's software and its maintenance in a validated state, in compliance with parent company requirements.
- Participate in the quality monitoring of service providers and other partners of the manufacturing site.
- Participate in the monitoring of the quality system in connection with the manufacturing site's activities.
- Participate in the processing and monitoring of deviations and associated action plan(s) concerning pharmaceutical specialties and the manufacturing site's activities.
- Ensure the updating of the manufacturing site's quality documents.
- Ensure the harmonization of the manufacturing site's quality documentation with Group procedures.
- Participate in the monitoring of activities related to the distribution of pharmaceutical specialties, particularly batch monitoring.
- Participate in providing quality assurance support to the various departments of the manufacturing site.
- Participate in the monitoring of the internal and external audit program concerning the manufacturing site's activities.
- Participate in the monitoring of changes relating to specialties and the manufacturing site.
- Prepare and submit the annual status reports for the manufacturing site.
- Participate in the continuous improvement of your area of responsibility.
Requirements
EDUCATION AND PREREQUISITES
- Master 2 in Quality Assurance, pharmacist, or engineer
- Dynamic, organized, proactive, and you enjoy working within a human-sized company
- Good writing skills and good communicator
- You are comfortable with the main software in the Office suite (Word, Excel, PowerPoint)
- You are able to use English both in writing and speaking in a professional context
- Initial experience at a manufacturing site and/or participation in a computerized system validation project would be a plus
What we offer
Why join ALK? You are joining a responsible and innovative company, driven by a concrete health mission: improving the quality of life for allergic people.
*CONTRACT: 4-month fixed-term contract REMUNERATION:** €42,000 to €45,000 gross annual
TELEWORKING: up to 2 days per week · CE Dynamic Open-access English learning platform
Other
JOB INFORMATION LOCATION: La Défense (92) </body>