QA Expert, Manufacturing Release

QA Expert, Manufacturing Release

Lonza

Stein, Switzerland

As a Quality Assurance Expert Manufacturing Release, you’ll play a key role in the release of drug product from our aseptic fill&finish lines, ensuring product quality requirements are met while providing rigorous oversight from technical transfer, manufacturing and release. Be part of a team that drives excellence and innovation in global healthcare!

What you will do:

• Perform batch release for aseptic manufactured drug product
• Write, review and approve deliverables (e.g. procedures, SOPs, risk assessments, gap assessments) and related data bases (e.g. training, validation) to ensure GMP compliance
• Review and approve documents in both electronic systems (e.g. MES) and paper-based. Approve change requests, deviation and CAPAs related to product and process
• Promote and enforce compliance to internal and external guidelines regarding quality and safety
• Ensure required level of knowledge and skills as well as identify competency gaps and solutions. Lead development and evaluation of new tools, processes, quality initiatives & plans
• Be present at the manufacturing line to watch and support with manufacturing-related activities
• Support projects and maintain Sterile Production Stein line functions in GMP compliance related issues

What we are looking for:

• Degree (BSc, MSc or PhD) in Natural Sciences, Pharmaceutical Sciences or related field
• Work experience in sterile drug product manufacturing OR sterile drug substance manufacturing in a GMP controlled environment
• Experience in deviation and change management is a prerequisite
• Work experience in QA is an advantage
• Hands on personality, you openly approach business partners, excellent influencing and negotiation skills
• Fluency in English is required, German language skills are an advantage