Job in der Schweiz: Quality Manager
Location
Freiburg im Breisgau | Germany
Job description
Job in Maennedorf:
Your tasks
- 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: Manage product validations, which includes coordination with relevant testing labs / support clean-room equipment qualifications / maintain the cleanroom (periodic testing / organize maintenance / take care of improvements) / work with our software developer team to transition to an electronic production based on GAMP5 guidelines and support the software validation (CSV) / set up batch records for our new products / 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 which 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 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 CV, reference letters and a brief explanation 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 Bewerben über hokify
Job tags
Salary
