Senior QA Specialist

Senior QA Specialist

Lonza

Visp, Switzerland

In Visp, we are looking for a QA specialist to join multifunctional QA Operations team in the Bioconjugates Business unit who will support to establish and maintain quality management & compliance processes. You will work closely with various quality, engineering and operational functions to ensure cGMP compliant manufacturing and documentation.

What you’ll do:

• Coordinate QA interests during different project phases.
• Responsible for project specific QA Operation tasks during Commissioning/Qualification.
• Responsible for review and final release of records such as Standard Operating Procedures (SOPs), Master Manufacturing.
• Batch Records, Material Specifications, Quality Risk Assessments, Deviations, CAPAs, Change Requests, Effectiveness Checks, Testing Protocols & Reports…etc.
• Managing independently stakeholders and their needs in a customer focused environment.
• Participate and support regulatory inspections and customer audits.

What we’re looking for:

• Bachelor’s or master’s degree in biotechnology, Biochemistry, or a related field.
• Significant experience in biopharmaceutical manufacturing, preferably in a QA function.
• Strong background in cGMP and broad knowledge in biotechnological manufacturing processes, validation approaches and risk management.
• Sound experience in representing Quality and Compliance in projects.
• Good communication skills and experience in interaction with all kind of interfaces within the organization.
• Experience in the use of the following systems would be preferred: TrackWise, LIMS, DMS and SAP.
• Excellent written and spoken English - knowledge of written and spoken German would be an advantage.