Senior Quality Assurance Specialist

Lonza; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Lonza in Visp is seeking a Senior QA Specialist for a 7-month, site-based contract. You will safeguard contamination control and oversee EMPQ and clean utilities with a focus on regulatory readiness. The role requires leading investigations, CAPA closures, and representing the site in customer audits and FDA/EMA inspections.

Ideal candidates bring 5+ years in GMP-biopharma QA, PQS experience, and strong environmental monitoring expertise, with English fluency and German being a plus.

Qualifikationen

• GMP experience in biologics/pharma required.
• 2+ years in Pharmaceutical Quality Systems (PQS), deviation management, CAPAs, and change controls.
• Experience with Environmental Monitoring Performance Qualification (EMPQ) and clean utilities.
• Degree in Microbiology or related science.
• Fluent written and spoken English; German a plus.

Aufgaben

• Ensure manufacturing facilities and clean utilities meet regulatory standards to deliver safe biopharmaceuticals.
• Provide QA oversight for premises and utilities qualification including EMPQ.
• Lead cross-functional investigations into monitoring excursions and deviations; define CAPAs.
• Represent site during customer audits and FDA/EMA inspections.
• Collaborate with operations teams to support new product introductions and facility changes.
• Analyze environmental monitoring data to identify trends and drive preventive actions.
• Drive continuous improvement of contamination control strategies and quality systems.

Kenntnisse

GMP experience

QA/Quality Assurance

Regulatory knowledge

EMPQ experience

CAPA & deviations handling

Audit readiness

English proficiency

German language skills (plus)

Ausbildung

Microbiology degree

Jobbeschreibung

Join our Quality team in Visp as a Senior QA Specialist, supporting end-to-end contamination control strategies and premises and utilities qualification on a 7-month contract.

This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Competitive hourly rate.

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What you will do:

• Safeguard public health by ensuring manufacturing facilities and clean utility systems meet strict regulatory standards to deliver safe biopharmaceuticals.
• Provide QA oversight for premises and utilities qualification, including Environmental Monitoring Performance Qualification (EMPQ) and clean utility systems.
• Lead cross-functional investigations into monitoring excursions, contamination incidents, and deviations, defining targeted CAPAs.
• Represent the site as a Pharmaceutical Microbiology Subject Matter Expert (SME) in front-facing customer audits and FDA/EMA regulatory inspections.
• Collaborate with growing operational teams of 10+ specialists to support new product introductions, facility adaptations, and process changes.
• Analyze and interpret environmental monitoring outputs, identifying trends to implement proactive risk‑based corrective actions.
• Drive continuous improvement of site contamination control strategies and quality management systems.

What we are looking for:

• Substantial GMP experience (5+ years) in the biologics or pharmaceutical industry within Quality Assurance or QC Microbiology.
• Proven track record (2+ years) within Pharmaceutical Quality Systems (PQS), deviation management, CAPAs, and change controls.
• Practical expertise in Environmental Monitoring Performance Qualification (EMPQ), cleanroom classification, and clean utilities (WFI, purified water, gases).
• Solid understanding of contamination control principles and regulatory requirements, including FDA, EMA, and EU Annex 1 guidelines.
• Degree in Microbiology or a relevant scientific discipline.
• Fluent written and verbal communication skills in English; German language skills are a strong plus.
• Strong problem‑solving mindset and ability to perform effectively in front‑facing audit environments.

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.

As Lonza’s talent acquisition partner, please note, Randstad is responsible for the engagement and contracting of this contingent role.