Senior QA Analytics Lead – GMP & Compliance

Lonza; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Lonza in Visp, Switzerland seeks a Senior QA Specialist for QA Analytics (80-100%). You will provide QA oversight on GMP-relevant activities in QC and Analytical Development, review SOPs and validation plans/reports, and ensure alignment with Pharmacopoeias and health authorities.

You will be part of cross-functional teams, support audits, and drive continuous improvement in analytical methods and GMP compliance. Fluency in English is essential; German knowledge is a plus.

Qualifikationen

• Academic degree in Chemistry/Biotechnology/Life Sciences or related field.
• Significant pharma industry experience in QC or QA.
• Analytical expertise with method validation.
• Knowledge of GMP incl. USP, EP, JP.

Aufgaben

• Represent QA concerns to the QC and Analytical Development departments and ensure GMP requirements are met and SOPs are followed.
• Review and approve SOPs, analytical test methods, method transfer protocols/reports, method validation protocols/reports, and OOX gLIMS investigations.
• QA supervision of OOX events during investigation in QC/AD departments: Review and approve out-of-specifications/expectations/trend results.
• Write or revise SOPs in your area of expertise and be the owner of these documents.
• Ensure compliance with GMP in the areas of stability testing and reference standards.
• Cooperation, review and approval of deviations (DRs), investigations (INVs), changes (CRs), and CAPAs within analytics (QC).
• Support inspection/audit.
• Ensure compliance of Lonza QC test methods with Pharmacopoeias where applicable.

Kenntnisse

Analytical method validation

cGMP regulations

Auditing

English proficiency

Regulatory interactions

Ausbildung

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

Jobbeschreibung

Lonza in Visp, Switzerland seeks a Senior QA Specialist for QA Analytics (80-100%). You will provide QA oversight on GMP-relevant activities in QC and Analytical Development, review SOPs and validation plans/reports, and ensure alignment with Pharmacopoeias and health authorities.

You will be part of cross-functional teams, support audits, and drive continuous improvement in analytical methods and GMP compliance. Fluency in English is essential; German knowledge is a plus.