We are a worldwide manufacturer of bespoke specialist filtration, mixing and single-use systems in the industrial, oil & gas, biotech, and chemical sectors. The company head office is located in Switzerland close to the city of Zurich, with subsidiary companies in China, Poland, India, United States of America, and Malaysia. We have trade delegates and agents in the major countries.
In order to strengthen our presence in the Pharma/Biotech industry, we are currently looking for an experienced QA professional to maintain and expand our cleanroom production that follows GMP guidelines, support us during the transition to a paper-less production, and take care of ISO 9001 related issues and audits. Furthermore, you will ensure high quality-related standards in our employees.
* Act as the main point of contact for all quality-related key topics regarding processes and related equipment.
* Improve and maintain the existing Quality Management System.
* Actively support Risk Assessments.
* Manage NCRs, 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.
* Operate closely with the production as well as Management team.
* Continue setting up a GMP-based production in our new cleanroom, which includes the following tasks:
o Manage product validations, which includes coordination with relevant testing labs.
o Support clean-room equipment qualifications.
o Maintain the cleanroom (periodic testing).
o Organize maintenance.
o Take care of improvements.
o Work with our software developer team to transition to an electronic production based on GAMP5 guidelines.
o Support the software validation (CSV).
o Set up batch records for our new products.
o Establish a change-control system.
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 and/or maintaining and operating clean rooms.
* 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 the effect it has on their daily routine.
* Fluency in English and German is required.
What we offer
Thanks to continuous investments, 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/Biotech industry, so you will be the person in charge when it comes to setting up the production environment for these machines.
Are you an experienced QA Professional who likes building up something from scratch and implementing 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 CV, reference letters, and a brief explanation of why you believe to be the right fit for the company – we are looking forward to hearing from you!
Please send your complete application in English to artemis.ghika@drm.ch.
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