Quality Assurance Engineer

Vor 2 Tagen

Lausanne, Schweiz GXP CONSULTING Switzerland Vollzeit

Do you have a passion for Life Sciences? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? So do we

GXP CONSULTING Switzerland is a Swiss consulting company with an experienced team of Life Sciences professionals. Since 2014, we deliver outstanding industry expertise and support to our clients in the complete range of product life cycle.

In order to continue to successfully support our many clients, we are currently looking for Quality Assurance Engineers Operations.

About the job:

  • Reviews batch records (API, raw materials, bulk, semi-finished, and finished products).
  • Handles deviations, CAPA, and Change Control and ensures the execution and follow-up of escalation processes.
  • Writes and assists with writing SOPs and further documents for QA.
  • Handles qualification and validation documentation (DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation) for QA review.
  • Handles the approval and qualification of suppliers, bulk, and packaging services, including participation in auditing and establishing Technical/Quality Agreements.
  • Actively contributes to Product Quality Reviews (PQR), Continuous Process Verification (CPV), and investigations as needed.
  • Ensures successful Authorities inspections by participating in the preparation and support in different roles (i.e. Backoffice, Subject Matter Expert, Scribe, or Runner).
  • Supports QC/QA transfers of new products/methods.

About you:

  • Experience in Quality Assurance in a pharma or biotech company.
  • Master's Degree (or equivalent) in Life Sciences or a related discipline.
  • Thorough understanding of cGMPs, Eudralex, and FDA 21 CFR regulatory requirements.
  • Excellent written and oral communication skills.
  • Languages: English (fluent); French and/or German is a big plus.

About us:

  • We are a human-sized company with great colleagues from diverse cultural and professional backgrounds.
  • We communicate openly and value feedback.
  • We work as a team where every member is valued and appreciated.
  • We propose continuous learning and development opportunities via internal trainings and workshops.
  • We offer a competitive salary package in line with industry practice, together with exceptional employment benefits.

At GXP Consulting Switzerland, everyone contributes to our joint success and grows individually

If you share the same passion and values, we will be glad to hear from you

#J-18808-Ljbffr

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