Engineering & Manufacturing
Schweiz, Zürich
Männedorf
100

Quality System Manager

Job-ID: 2803

About our client

Our client is a global manufacturer of processing machines, which are sold to clients all over the world. Their Headquarter is based in the region of Zurich, where parts of the production are also attached. In order to strengthen their focus on the Pharmaceutical industry, we`re looking for an experienced QA Professional to build up a clean room based on GMP guidelines, implement a QA-oriented company culture as well as related reviewing and recording processes. Furthermore you`ll foster a strong understanding of Good Manufacturing Practices (GMP) by the employees.

Tasks

  • Act as the main point of contact for all quality-related key topics regarding processes and related equipment
  • Set up GMP production in a new Cleanroom
  • Improve and maintain the existing Quality Management System
  • Periodic qualifications and validations of GMP relevant cleanroom production equipment
  • In the mid-term oversee the manufacturing process of the processing machines
  • Review and approve various GMP documents including batch records
  • Review investigations, change controls and oversee the period of use, dosing and administration instructions
  • Actively support Risk Assessments (FMEAs)
  • Manage CAPAs and periodic reviews in a proactive way
  • Act as the main point of contact for regulatory inspections
  • Contribute to both customer and supplier audits
  • Support of the Commissioning and Qualification activities during Factory Acceptance Tests (FATs) as well as on Site (Site Acceptance Tests)
  • Operate closely with the production as well as Management team

Your profile

  • Bachelor`s Degree in Chemical Engineering, Bioengineering or Pharmacy
  • Minimum of five years of experience in a Quality Assurance role in a Pharmaceutical Manufacturing Environment or similar
  • Strong know-how of QA-related ways of working
  • Experience in building up clean rooms and maintaining those
  • Experience with QA-related tools such as CAPAs, FMEAs, etc.
  • Experience in conducting both external and internal audits
  • Ability to work independently as well as in a team
  • You describe yourself as an inspiring leader and someone, who is able to support employees in understanding GMP guidelines and which effect it has on their daily routine
  • Fluency in English is required, German would be a big advantage

What`s on offer?

Thanks to continuous investments in the Swiss location, the company offers you a secure role within a growing business. Over the last couple of years the company has developed specific product lines to supply the Pharmaceutical industry, so you`ll be the person in charge when it comes to set up the production environment for these machines. Are you an experienced QA Professional, who likes building up something from scratch and to implement new ways of working for the existing employees? Do you enjoy working in a Swiss medium-sized company with a direct impact on relevant Management decisions?
Feel free to apply directly with your current CV and a brief explanation why you believe to be the right fit for the company – we`re looking forward to hearing from you!

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Dominik Müller

Co-Geschäftsführer & Partner

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