Senior QA Specialist, Bioconjugates

Senior QA Specialist, Bioconjugates

Lonza

Visp, Switzerland

In this role you will specify quality requirements for manufacturing processes and ensure that manufactured products comply with cGMP standards over their entire life cycle. As a Quality representative you will be a key member in cross-functional project teams ensuring measures for product safety quality & compliance are implemented. You will have full QA oversight of a product and manage the project from Quality perspective.

Key responsibilities:

• Own all quality related responsibilities related to new facility operational readiness and manufacturing processes and representing QA in project organization
• Perform assessments for all process-related changes and be responsible for review and final approval 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.
• Support the release of Drug Substance batches
• Support the investigations of customer product complaints and assure the completion of the appropriate documentation
• Represent QA in project/tech transfer organizations for new biotech manufacturing processes and coordinate QA interests during the different project phases
• Make quality decisions for the respective projects in internal and external meetings
• Involved in customer audits as well as in regulatory inspections and support all activities to ensure inspection readiness of the department

Key requirements:

• University Degree in Biotechnology/Biology/Chemistry/Life Science or related field
• Significant experience in the area of biopharmaceutical manufacturing, preferably in a QA function
• Strong background in cGMP and broad knowledge in biotechnological manufacturing processes, validation approaches and risk management
• Good communication skills and experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
• Experience in the use of the following systems would be preferred: TrackWise, LIMS, DMS and SAP
• Proficient written and spoken English, good German language skills - an advantage

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