Senior QA Specialist Microbial

Lonza

Visp, Switzerland

We are excited to offer an outstanding chance for a highly motivated individual to join our team in Visp as a Senior QA Specialist Microbial (f/m/d). You will report to the QA Operations Team Lead Large Scale Microbial and work in close collaboration with different quality and operations functions in order to ensure cGMP-compliant manufacturing activities and documentation.

Key responsibilities:

Responsible for managing daily activities related to quality, including campaign preparation, change control, deviation & CAPA management, and process monitoring. Ensures manufacturing processes are cGMP-compliant for clinical and commercial supply;
Ensure efficient cGMP-compliant life cycle management of all manufactured products, holding the authority to make quality decisions for projects in both internal and external meetings;
Act as the main customer point of contact for all project-related quality requests, providing timely and accurate information;
Offer mentorship to all Lonza departments, evaluating project-specific risks and ensuring strict adherence to cGMP by identifying areas of non-compliance through detailed risk assessments;
As the project lead, you will conduct internal and external audits. You will also act as the QA Subject Matter Expert (SME) during client audits. Additionally, you will take part in regulatory inspections conducted by health authorities.

Key requirements:

Bachelor or Master of Science in Life Sciences (e.g. Chemistry, Biotechnology, or a related field) and equivalent experience in the field;
Extensive experience in the GMP-regulated pharmaceutical or API industry is highly advantageous;
Proven ability to identify non-compliance and gaps from quality standards, with a keen eye for detail;
Experience in close collaboration with different functions and departments to achieve common goals;
Structured, detailed, and well-organized working attitude; open-minded to new ideas and suggestions; agile, highly motivated, and dynamic drive;
Proficiency in English is essential, and basic German skills are an advantage.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job