Senior QA Engineer, GMP & Compliance

Amaris Consulting; Vionnaz; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Amaris Consulting is seeking a QA Engineer to join our Valais, Switzerland team. The role focuses on GMP-compliant quality assurance for manufacturing and QC activities, with responsibilities including review of batch records, SOPs and validation reports, and leading CAPA and change control processes.

You will support internal and health authority audits, monitor KPIs, and drive continuous improvement within a robust QMS framework, with strong emphasis on data integrity and cross-functional

Qualifikationen

• Experience in QA in GMP environment is essential.
• Strong knowledge of EU GMP, ICH guidelines, and local health authority requirements.
• Experience reviewing batch records, SOPs, validation protocols and reports.

Aufgaben

• Ensure compliance of manufacturing and QC activities with GMP and regulatory requirements.
• Review and approve batch records, SOPs, validation protocols and reports.
• Manage quality events: deviations, OOS/OOT, complaints, change controls and CAPA.
• Participate in implementation and improvement of the QMS.
• Prepare and support internal audits, customer audits and inspections.
• Monitor quality KPIs and perform trend analyses for improvements.
• Contribute to product quality reviews and ensure data integrity.

Kenntnisse

GMP knowledge

Audit & inspections

QMS

Documentation review

English fluency

Jobbeschreibung

Amaris Consulting is seeking a QA Engineer to join our Valais, Switzerland team. The role focuses on GMP-compliant quality assurance for manufacturing and QC activities, with responsibilities including review of batch records, SOPs and validation reports, and leading CAPA and change control processes.

You will support internal and health authority audits, monitor KPIs, and drive continuous improvement within a robust QMS framework, with strong emphasis on data integrity and cross-functional