Senior QA Specialist Microbial

Lonza

Visp, Switzerland

As Senior QA Specialist Microbial you are owning all quality related responsibilities for the daily activities of API manufacturing processes for large scale production. Being one of the main stakeholder for quality assurance in production, you are working together with others in a middle sized team on projects.

Key responsibilities

Responsibility for batch releases and accountability for the quality of all related records (Deviation, changes, investigation, CAPA)
QA oversight for the dedicated manufacturing project
Single point of contact for the coordination of quality-related topics with customers
Make quality decisions for dedicated projects in internal and external meetings
SME for clients audits and participate in regulatory inspections of health authorities
Support and initiation of continuous Improvement projects and activities
Compiling, verifying and final release of records like Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Testing Protocols & Reports etc.

Key requirements

Master Degree in natural sciences (e.g. Biology, Biotechnology), or Bachelor degree with substantial work experience
Significant work experience in a GMP related pharmaceutical environment; preferable within a Quality unit
Experience handling/managing stakeholder on different levels
Knowledge in the usage of LIMS and TrackWise would be an advantage
Fluent language skills (written and oral) in English, German skills are preferred as addition

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