GxP and Medical Device Compliance Services
 


Quality / Validation Engineer - Pharma

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

 

Role & Responsibilities

  • Leading Quality Engineering activities for design, development and GxP manufacturing to ensure a high level of process and product quality

  • Develop, review and improve requirements, specifications, product plans and product drawings

  • Own and coordinate Qualification/Validation (incl. IQ, OQ, PQ) activities such as: Equipment qualification, production process validation, room qualifications etc.

  • Review/approve product and process change control documentation and specifications

  • Contribute to the development and improvement of design and manufacturing for existing and new products

  • Provide Technical Assessments to Change Controls/CAPA’s, Non-Conformities and Technical Suppliers Qualification
     

Position Requirements

  • Master’s  or Bachelor’s degree in Engineering, Bio-Pharma or another relevant life science discipline

  • In depth knowledge in Quality Engineering activities for design, development and manufacturing

  • At least 2-3 years experience in Qualification/Validation (IQ, OQ, PQ) activities such as: Equipment qualification, production process validation, room qualifications etc.

  • Working experience of validation systems for use in a EMA and FDA regulated environments

  • 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

  • Proficient use of MS Office suite and relevant database application

  • Fluency in German, English and French is required, 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 Compliance Expert
 

Consultys - At a glance
Consultys

Consultys is a specialist 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.