Senior QA Operations Specialist - GMP & Batch Release

Bachem; Vionnaz; On-site; CHF 110,000 - 150,000; Full time

Job summary

Bachem in Vionnaz, Switzerland, seeks a Senior Specialist QA – Operations to ensure GMP compliance across manufacturing activities and partner with operational teams on site projects.

The role involves batch release coordination, CAPA reviews, investigations, change control, QA approvals, and audits. Fluent English and French are expected; German is a plus. This is a full-time on-site position with opportunities for professional development.

Qualifications

• 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 escalate when needed.
• Solution-oriented mindset with a strong customer and service focus.

Responsibilities

• 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.

Skills

QA Operations

GMP compliance

Analytical thinking

Communication skills

Decision making

Education

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

Job description

Bachem in Vionnaz, Switzerland, seeks a Senior Specialist QA – Operations to ensure GMP compliance across manufacturing activities and partner with operational teams on site projects.

The role involves batch release coordination, CAPA reviews, investigations, change control, QA approvals, and audits. Fluent English and French are expected; German is a plus. This is a full-time on-site position with opportunities for professional development.