QA Projects Lead - GMP Compliance & Process Validation

Bachem Holding AG; Bubendorf; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Benefits dieser Stelle

Development opportunities

Flexible working hours

Home office days

Vacation days via workload reduction

Daycare center on campus

Pension fund 60% coverage

Discount platform

Staff restaurant

Sports activities

Zusammenfassung

Bachem Holding AG in Bubendorf is seeking a dedicated Manager QA Projects (a), 100% to strengthen the Quality Assurance team. You will represent QA in product-related projects at the Bubendorf site and ensure cGMP compliance across Production, QC and Project Management.

Responsibilities include defining control and lifecycle strategies from development through process validation to commercial manufacturing, reviewing GMP documents, changes, deviations and CAPAs, and acting as a key contact for

Qualifikationen

• Strong QA knowledge and cGMP understanding.
• Experience supporting process validations including risk management.
• Excellent verbal and written communication in German and English.

Aufgaben

• Represent QA in product-related projects at the Bubendorf site.
• Define control strategies and lifecycle strategies from GMP development through process validation to support commercial manufacturing.
• Review and approve GMP documents, changes, deviation reports, and CAPAs.
• Serve as the contact point for internal and external stakeholders on QA matters and coordinate with other departments.

Kenntnisse

QA knowledge

cGMP knowledge

Process validation

Risk management

Communication skills

German & English

Ausbildung

Master's or PhD in chemistry, biology, pharmacy or similar technical field

Jobbeschreibung

Bachem Holding AG in Bubendorf is seeking a dedicated Manager QA Projects (a), 100% to strengthen the Quality Assurance team. You will represent QA in product-related projects at the Bubendorf site and ensure cGMP compliance across Production, QC and Project Management.

Responsibilities include defining control and lifecycle strategies from development through process validation to commercial manufacturing, reviewing GMP documents, changes, deviations and CAPAs, and acting as a key contact for