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

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

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

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

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.