Senior QA Specialist - GMP Analytics & Compliance

Lonza; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Career growth

Inclusive culture

Competitive compensation

Location-based benefits

Zusammenfassung

Lonza in Visp, Switzerland, is seeking a Senior QA Specialist for Analytics to ensure GMP oversight across QA, QC, and Analytical Development activities, including external DP final samples. You will review SOPs, methods, and validation plans, and support cross-functional teams to meet health authority expectations.

You will collaborate on deviations, CAPAs, investigations, and audits, ensuring GMP compliance and quality documentation across analytics and stability areas.

Qualifikationen

• Academic degree in Chemistry/Biotechnology/Life Sciences or related field.
• Significant pharma industry experience; preferably in QC or QA.
• Established analytical expertise and experience with analytical method validation.
• Strong background in cGMP regulations; incl. USP, European- and Japanese Pharmacopoeia.
• Auditing experience and interaction with health authorities (FDA, Swissmedic, etc.).
• Excellent verbal and written English; German knowledge is advantageous.

Aufgaben

• Represent QA concerns to QC and Analytical Development to ensure GMP compliance and SOP adherence.
• Control and release of GMP-relevant documents for QC/AD.
• Review and approval of SOPs, analytical methods, transfer protocols and validation reports.
• QA supervision of OOX events during investigations in QC/AD.
• Write or revise SOPs in your area of expertise and own these documents.
• Ensure GMP compliance in stability testing and reference standards.
• Cooperate on deviations, investigations, changes and CAPAs within analytics (QC).
• Support inspections/audits.
• Ensure Lonza QC methods align with Pharmacopoeias where applicable.

Kenntnisse

QA

GMP compliance

Analytical method validation

cGMP regulations

Auditing experience

English (verbal/written)

German knowledge advantageous

Ausbildung

Bachelor's/Master's degree in Chemistry/Biotechnology/Life Sciences or related field

Tools

gLIMS investigations

Jobbeschreibung

Lonza in Visp, Switzerland, is seeking a Senior QA Specialist for Analytics to ensure GMP oversight across QA, QC, and Analytical Development activities, including external DP final samples. You will review SOPs, methods, and validation plans, and support cross-functional teams to meet health authority expectations.

You will collaborate on deviations, CAPAs, investigations, and audits, ensuring GMP compliance and quality documentation across analytics and stability areas.