Senior QA Specialist - Onsite Quality & Tech Transfer Lead

Lonza Group AG; Eyholz; Presencial; CHF 55.000 - 83.000; Tempo integral

Benefícios oferecidos por esta vaga

Agile career

Inclusive workplace

Competitive hourly rate

Resumo da vaga

Lonza Group AG is seeking a Senior QA Specialist to lead QA oversight during commissioning, qualification, and tech transfer activities at our Visp site. You will make risk-based decisions on deviations to ensure continuous cGMP compliance and review critical GMP records in alignment with procedures.

The role requires collaboration with cross-functional teams, experience with shop-floor manufacturing, and strong knowledge of quality risk management and ERP systems.

Qualificações

• Bachelor of Science in Life Sciences or related field is required or equivalent experience.
• Proven QA or operational compliance experience within a regulated pharmaceutical cGMP environment.
• Experience supporting shop-floor manufacturing, qualification, or technical transfer projects.
• Knowledge of quality risk management methods (e.g., FMEA) and electronic quality management/ERP systems (TrackWise, SAP).
• Excellent collaboration and communication skills with full professional fluency in English.

Responsabilidades

• Drive project-specific QA oversight during commissioning, qualification and tech transfer.
• Make timely, risk-based decisions on shop-floor events and deviations to maintain cGMP compliance.
• Review and approve critical GMP production and batch records per procedures.
• Assess, manage and mitigate quality risks affecting manufacturing using structured tools like FMEA.
• Partner with Manufacturing, Engineering, and Quality Control to align milestones.
• Participate in facility walkthroughs, internal audits, and regulatory inspections.
• Serve as a quality mentor and operational advisor on the production floor.

Conhecimentos

Quality Assurance

Regulatory compliance

English fluency

FMEA

Formação

Bachelor of Science in Life Sciences or related field

Ferramentas

TrackWise

SAP

Descrição da vaga

Lonza Group AG is seeking a Senior QA Specialist to lead QA oversight during commissioning, qualification, and tech transfer activities at our Visp site. You will make risk-based decisions on deviations to ensure continuous cGMP compliance and review critical GMP records in alignment with procedures.

The role requires collaboration with cross-functional teams, experience with shop-floor manufacturing, and strong knowledge of quality risk management and ERP systems.