Consultys is a specialist Life Science compliance consultancy firm in Switzerland, Germany, France and Belgium. Our experts develop strategies and solutions that help our customers manage even the most complex of problems. Is compliance and quality your kind of work? Then we're the right company for you. Consultys offers you great career opportunities as well as a broad internal and external training programs.
Your primary focus will be on the management and delivery of project work to our clients, aiming to constantly meet and even exceed client expectations.
To be successful in this role you will work as part of a team of industry specialists providing consulting services to major MedTech and Pharma firms, so you'll quickly build upon your existing industry knowledge to become an expert in your field.
We offer you a work environment dominated by a strong team spirit that will allow you to develop both professionally and personally.
Our projects often have a strong international flare and offer you the chance to work independently. You will join our motivated, multicultural team on our projects.
Support our team and Senior Experts in harmonization of (Global) Quality Management Systems
Writing Quality risk management (QRM) concepts with the corresponding SOPs, templates and tools
Execute Gap Analyses of the Q-Manuals against relevant Guidelines and Regulations
Developing and implementing QMS (Policies/SOPs) improvements of our clients
Writing of Global Quality Standards and Review incl. correction of SOP landscapes
Ensure complied GxP documentation systems (incl. IT systems) of our clients
Conception and Implementation of Supplier Quality Agreements
Handling of Change Control Requests, Non-Conformities and CAPAs, ensuring their adequate and timely closure from QA perspective
Support tech transfer and analytical method transfer activities
Master’s or Bachelor’s degree in Pharmacy, Bio-Engineering or another relevant life science discipline
Preferably at least 1 years of experience in a GxP environment or regulatory agency, include direct contact with regulatory agencies
Familiarity with Swiss and (if applicable) EU, U.S. (FDA) legislation procedures and guidelines governing pharmaceutical products; knowledge of the quality GxP framework
Good understanding of IT systems and data modeling incl. process design (MS Visio, MS Office, SAP, etc.)
Strong attention to detail; proven ability to successfully handle conflicting priorities
Ability to communicate well verbally and in writing is essential
Demonstrated diplomacy and assertive skills in dealing with internal and external parties
A mature and disciplined approach to work is essential
Pronounced client focus and business orientation
Strong organizational and business planning skills
Proficient use of MS Office suite and relevant database application
Fluency in English is required, German, French or Italian would be a plus
Hands-on personality, with flexibility and dedication to maximize our client`s value