Biogen Quality Assurance Associate – Warehouse in Luterbach, Switzerland
You are managing* root cause analysis, impact assessments* and corrective actions for* QC* and Warehouse related minor and major and critical deviations.
You will support the activities related to the documentation of* Drug Substance Batch* disposition.
You review, revise and approve Standard Operating Procedures (SOP).
You collect data for metrics and identification of negative trends and you support the QA *and regulatory affairs units with *audits *and *inspections.
You have a first solid experience in a* Quality Assurance* position within a *manufacturing *environment in a pharmaceutical, biotech or medical device industry.
You have prior quality experience working with QC, QA and/or warehouse.
You possess GxP knowledge of regulations.
You have ideally Oracle, TrackWise, LIMS and elogbook management experience
As Quality Assurance Associate, Warehouse *you are responsible that all operations meet or exceed *cGMP regulations related to Bulk Drug Substance.
You are accountable for providing Quality Assurance input and oversight for Quality Control activities, QA Release and warehousing. You will in addition analyse quality key metrics in order to support Bulk Drug Substance operations.
You support on the management of Project Implementation such as a New Product Introduction.
You will report to the Quality Assurance Manager and work cross-functional with different quality units (QC, Product Quality, Corporate Quality, QA).