Senior QA Specialist - QA Operations Microbial

Senior QA Specialist - QA Operations Microbial

Lonza

Visp, Switzerland

What you’ll do:

• Own all quality related responsibilities for the daily activities (like campaign preparation, change control, deviation & CAPA management, process monitoring) of API manufacturing processes for clinical and commercial supply;
• Ensure an efficient cGMP compliant life cycle management of all products manufactured and have the authority to make quality decisions for the project in internal and external meetings;
• Main customer point of contact for all project related quality requests;
• Provide cGMP guidance to all Lonza departments and assess project-specific risks and internal adherence to cGMP by identifying areas of non-compliance through risk assessments;
• Project responsible for internal & external audits; QA SME for clients audits and participate in regulatory inspections of health authorities.

What we’re looking for:

• Academic degree in Life Science (e.g. Chemistry/Biotechnology or other related field);
• Experience in the GMP regulated pharmaceutical/API industry is an advantage;
• Ability to identify non-compliance and gaps from quality standards;
• Experience collaborating closely with different functions and departments;
• Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive;
• Fluency in English language and basic German skills are an advantage.