GxP and Medical Device Compliance Services
 

 

Junior LifeScience GxP Quality
Consultant (Engineering / Labs)

Location:   Zurich / Zug / Lausanne
Country:    Switzerland
Role:           Subject Matter Expert (SME)
Team:         Pharma / Biotech

 

Summary

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.

 
What you can expect from us

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.

Role & Responsibilities

  • 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

Position Requirements

  • 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 German and English is required, French or Italian would be a plus

  • Hands-on personality, with flexibility and dedication to maximize our client`s value

 

At a glance - Working as a Consultys Junior Compliance Consultant
 

Prismond Group - At a glance
Consultys Group

Consultys is a LifeScience service company with diverse career opportunities. We link operational compliance, quality assurance, regulatory and own solutions in ways that master complex compliance challenges to help our Pharma, Medical Devices and BioTech clients in the regulated environment.
Prismond Group - Boost our career
Boost your career

A consultant position with Consultys boosts your career, as you benefit from interesting, hands-on compliance projects, internal and external trainings, 1:1 mentoring and the expertise of our passionate experts.
Perks and Benefits

Consultys offers a wide range of benefits and opportunities for your professional development. Flat hierarchies, consulting with a partnership approach and a close-knit family atmosphere are essential elements of our company culture. Whether you join us as an intern, a recent graduate or a senior hire, Consultys offers great perks and benefits.

Take Action - Apply Now.


Please submit your online application in English or German language.

For further information, please contact our local Human Resources department.