QA Associate.
Softhale N.V. is a privately held Belgium-based respiratory company focused on the development of pharmaceutical products with superior clinical performance based upon differentiated technology delivered by our next generation Soft Mist Inhalation (SMI) device to the lungs.
The Company’s proprietary, propellant-free, purely mechanical device delivers medication to the lungs more effectively than other types of inhalers and is poised to change the treatment paradigm in large markets including asthma and COPD. Softhale’s products to be used for pharmaceutical development and approval processes are innovative as well as cost-optimized.
Job omschrijving.
To support the development, maintenance and adherence to the Softhale Quality Management System (QMS) in Softhale.
Document Control:
- Maintenance of controlled document standards, issue, and archive
- Maintenance of SOP training system including auditing of Training Files
Compliance Monitoring:
- Maintenance and follow-up of CAPA and Change Control systems
- Maintenance, compilation, and analysis of Quality metrics
- Preparation of materials for Quality System Reviews
Supporting work in the following area:
- Maintenance of company certifications (ISO 13485)
- QA review of project documents and records as necessary
- QA review of vendor company quality documents and records as necessary
- Preparation and reporting of internal and external audits
- Continuous Improvement (CI) of the documents and systems of the QMS
Profiel van de kandidaat.
- Degree in Pharmaceutical Life Sciences or related fields
- Knowledge of local and international regulatory requirements
- Background and experience of 2 - 5 years in QA
- Experience in the pharmaceutical industry - in GCP, PV, GDP and GMP is a plus
- You are fluent in Dutch and English, both written and spoken
- Outlook 365 experience is a must,other Quality software is a plus
- You are pro-active, love to solve problems, you like to be challenged, autonomous, out the box thinker
Werkomstandigheden.
You will start in a fast growing innovative company. At this moment in time, they are at a critical point of the development. You will join their mission to further advance and broaden the development of their platform and to build and launch a new generation of highly effective inhalable medicines on a global scale. Beside a great opportunity, you will receive a competitive salary.Contact.
If you are interested in this position and would like to know more about it, please contact:
Nele Geusens, PhD, Recruitment Consultant
T: +32 497 57 08 94
E: geusens@themagroup.eu