Senior QA Specialist - GMP Analytics (Relocation)

Lonza; Schweiz; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile career culture

Inclusive workplace

Performance-based compensation

Benefits in Visp

Zusammenfassung

Lonza in Visp, Switzerland is seeking a Senior QA Specialist (f/m/d) for Analytics to ensure quality oversight on GMP-relevant activities across QC and Analytical Development, including review and approval of SOPs, methods and validation reports, and for external DP final samples.

You will represent QA in cross-functional projects, write or revise SOPs, supervise OOX events, support inspections, and ensure harmonized GMP compliance with pharmacopoeias. Relocation assistance available.

Qualifikationen

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

Aufgaben

• Represent the QA concerns to the Quality Control (QC) and Analytical Development (AD) departments and ensures that GMP requirements are met and SOPs are followed
• Control and release of GMP-relevant documents of the QC / AD
• Review and approval of SOPs, analytical test methods, method transfer protocols/reports, method validation protocols/reports, and OOX gLIMS investigations issued be the QC/AD departments
• 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

QA expertise

Analytical method validation

cGMP regulations

Auditing experience

English communication

German knowledge

Ausbildung

Bachelor's or higher in Chemistry/Biotechnology/Life Sciences

Jobbeschreibung

Lonza in Visp, Switzerland is seeking a Senior QA Specialist (f/m/d) for Analytics to ensure quality oversight on GMP-relevant activities across QC and Analytical Development, including review and approval of SOPs, methods and validation reports, and for external DP final samples.

You will represent QA in cross-functional projects, write or revise SOPs, supervise OOX events, support inspections, and ensure harmonized GMP compliance with pharmacopoeias. Relocation assistance available.