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Biogen Quality Assurance Associate, Manufacturing in Luterbach, Switzerland

  1. You work on the field, having an oversight over the manufacturing operations from a quality point of view and the electronic batch record review (QRM). 2. You will perform ad hoc sampling and testing 3. You contribute to the root cause analysis and corrective actions for product and process related non-conformances as SME quality for minor and major deviations. 4. You review, revision and approve Standard Operating Procedures (SOP) *review, revision & approval. 5. 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 solid experience in a* Quality Assurance* position within a manufacturing environment in a pharmaceutical, biotech or medical device industry. * 3+ years of quality assurance and/or operation experience in pharmaceutical or biotech manufacturing environment * Good experience of process design and improvement * You posses GxP knowledge of regulations. * You have ideally Electronic Batch Record and elogbook management experience As Quality Assurance Associate, Manufacturing you are responsible that all operations meet or exceed cGMP regulations on the manufacturing field. You collaborate with the daily manufacturing- and facility operations from a quality perspective, facilitating activities related to the quality Bulk Drug Substance and cell bank. * You will work mostly in the field, side by side, the manufacturing department and because of this unique position you are able to offer; reactive support of discrepancy identification; effective resolutions; *root cause analyses and corrective actions for product and process related non-conformities. You will report to the Quality Associate Lead and work cross-functional with different quality units (QC, Product Quality, Corporate Quality, QA). You work in a 5-shift model along side the manufacturing team, within this you will work with 3-5 QA colleagues per shift and your QA Lead.