48 days ago on searchapp-695.umantis.com

Sr. Quality Assurance Associate European operations

AurigaVision AG

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 Please refer to JobSuchmaschine in your application

Sr. Quality Assurance Associate European operations





Vollzeit / Temps complet




For our customer, an international pharmaceutical company with its newly set up European headquarters in Switzerland in the Zug area, we are mandated to search for an experienced and highly motivated

Sr. Quality Assurance Associate
European operations

Sr. Quality Assurance Associate European operations


This position will directly report to the Manager of European Quality Operations and support the manufacturing and testing of clinical and commercial CMP materials by providing Quality oversight of contract manufacturing organizations.


  • Acting as a quality contact with CMO quality organizations, manufacturing a diverse range of GMP materials (small molecules, biologics, sterile injectables)
  • Overseeing the quality of packaging and labeling operations of clinical trial material including reviewing of executed records
  • Reviewing and providing input on deviations/investigations related to manufacturing and testing
  • Reviewing cGMP controlled documents such as master batch production records, test methods, specifications and manage implementation of changes
  • Reviewing executed batch production records to ensure compliance with approved procedures and GMP expectations
  • Conducting external audits of CMO’s and other service providers, write audit reports and follow up on observations/CAPAs
  • Authoring and/or revising standard operating procedures and associated work instructions
  • Performing person in the plant oversight including on-site quality support during Process Performance Qualification (validation) activities
  • Interfacing diligently with US Quality team to ensure efficient and effective communication on project status and issues


Your profile:

  • Minimum of BSc in a scientific discipline (Chemistry, Biology, etc.)
  • You
    min. 5 years of experience in the regulated pharma industry and in the field of Q.A.
  • You have a strong knowledge and experience with US/EU GMPs, ICH and other applicable international regulations
  • You have experience with the production and testing of APIs (biologic or small molecules)
  • You have experience with sterile injectables and secondary packaging
  • Business fluency
    in English

    Would you be interested in working in a very dynamic and fast evolving company
    in the central part of Switzerland? We look forward to receiving your application with referral on reference number 1244 on www.aurigavision- stellenmarkt.ch or by mail to jobs@aurigavision.com. Full discretion guaranteed.




Baarerstrasse 139
6300 Zug