Senior Quality Assurance Engineer Role

Vor 5 Tagen


Lausanne, Waadt, Schweiz GXP CONSULTING Switzerland Vollzeit
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.

Qualification and validation documentation (DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation) for QA review.

Approves and qualifies suppliers, bulk, packaging services including participation to auditing and establishing Technical/Quality Agreements.

Actively contributes to Product Quality Reviews (PQR), Continuous Process Verification (CPV); and to investigations as needed.

Ensures successful Authorities inspections by participating in preparation and support in different roles.

Supports QC/QA transfers of new products/methods.

About You:

Experience in Quality Assurance.

Master Degree (or equivalent) in Life Sciences.

Thorough understanding of cGMPs, Eudralex, and FDA 21 CFR.

Languages: English (fluent), French and/or German is a plus.



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