Senior QA Operations & Compliance Specialist

Bachem; Vionnaz; A distancia; CHF 110.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Dynamic work environment

Professional development opportunities

Competitive employee benefits

Descripción de la vacante

Bachem in Vionnaz is seeking a Senior Specialist QA – Operations (a) 100%. You will ensure GMP compliance across manufacturing activities and partner with operations and site projects to drive quality improvements.

Responsibilities include batch release, CAPA review, investigations, change control, and audits. Requires a Master’s in a related field and 5+ years in pharma/chemical QA with strong GMP knowledge; French and English fluency are essential.

Formación

• Master’s degree in Engineering, Chemistry, Pharmacy, or a related field.
• Minimum 5 years of experience in the pharmaceutical or chemical industry; QA Operations experience is highly desirable.
• Strong knowledge of GMP requirements and their practical application in a manufacturing environment.
• Ability to independently assess issues, make sound decisions, and appropriately escalate where needed.
• Solution-oriented mindset with a strong customer and service focus.
• Excellent organizational and communication skills.
• Fluent in French and English, both written and spoken; German is an asset.

Responsabilidades

• Coordinate and perform batch release activities for finished products and intermediates.
• Review and approve quality events, root cause analyses, CAPAs, and effectiveness checks.
• Support and approve laboratory investigations.
• Assess, coordinate, and approve change requests.
• Review and approve master manufacturing documentation.
• Approve qualification protocols and reports for facilities and equipment.
• Conduct internal and external audits and support customer and regulatory inspections.
• Represent Quality Assurance in site projects and contribute to SOP creation and revision.

Conocimientos

GMP knowledge

Quality Assurance

Analytical thinking

Decision making

Educación

Master's degree in Engineering, Chemistry, Pharmacy or related field

Descripción del empleo

Bachem in Vionnaz is seeking a Senior Specialist QA – Operations (a) 100%. You will ensure GMP compliance across manufacturing activities and partner with operations and site projects to drive quality improvements.

Responsibilities include batch release, CAPA review, investigations, change control, and audits. Requires a Master’s in a related field and 5+ years in pharma/chemical QA with strong GMP knowledge; French and English fluency are essential.