Senior QA Specialist, QA Analytics 80-100% (f/m/d)

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

Location:

The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

As a Senior Quality Assurance (QA) Specialist (f/m/d) for Analytics, you will ensure the Quality oversight on GMP-relevant activities carried out by the Quality Control and Analytical Development (AD) departments, also for externally formulated drugs (external DP final samples). This includes the review and approval of SOPs, analytical methods/specifications and validation plans/reports assuring their compliance to Lonza’s standards, customer’s requirements and health authority expectations (Pharmacopoeias). Moreover, as a Quality and Compliance representative, you are a key member of cross-functional project teams.

What you will get:

• An agile career and dynamic working culture




• An inclusive and ethical workplace




• Compensation programs that recognize high performance




• A variety of benefits dependant on role and location




• Benefits in Visp: https://bit.ly/3wjkoFi

What you will do:

• 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.

What we are looking for:

• 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.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.