Senior QA Specialist, QA Operations

Senior QA Specialist, QA Operations

Lonza

Visp, Switzerland

Currently we are looking for several Senior QA Specialists (f/m/d), who will work on our new growth project. As a member of a CAPEX projects Quality Project team, you will manage the QA related activities in close contact with QC, Engineering and Manufacturing to ensure the quality oversight is given. You will ensure timely delivery of project, even in the face of project requirements and priorities through excellent planning and management of the project.

What you will do:

• Responsible for project specific QA Operation work during commissioning/qualification and project tech transfer in IBEX
• Assess and manage tasks that would impact Quality operation during GMP manufacturing
• Plan for future activities and coordinate with other departments (e.g. QC, Engineering, Manufacturing) to complete the planned activities
• Support day-to-day Quality Assurance activities in accordance with approved SOPs/Policies for a GMP manufacturing facility
• Review GMP records to ensure compliance with cGMP per written procedures
• Make real-time decisions on process events on the floor, based on knowledge of defined SOPs & policies
• Participate in walkthroughs and audit/inspections

What we are looking for:

• Academic degree in Life Sciences or a related field
• Significant experience in the pharmaceutical Quality area
• Work experience in a role in Quality Assurance, Production or Engineering, in pharmaceutical industries and cGMP regulated environment
• QA experience in tech transfer is preferred
• Excellent knowledge of computer systems (e.g. TW, SAP, etc.) and quality tools such as risk based approaches (e.g. FMEA)
• Fluent English (written&verbal) is required