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Biogen Quality Assurance Supervisor, Manufacturing in Luterbach, Switzerland

  1. You Manage *(including their development) the Solothurn Quality Associates team who themselves are responsible for specific functions according to their job descriptions. Through your expertise you are able to take decisions and organize and escalate situations to ensure the *compliance of the manufacturing activities are guaranteed. 2. 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). 3. You will perform ad hoc sampling and testing 4. 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. 5. You review, revision and approve Standard Operating Procedures (SOP) *review, revision & approval. 6. You collect data for metrics and identification of negative trends and you support the *QA *and regulatory affairs units with *audits *and *inspections. * Bachelor in Science / Engineering in Life Science or Technical discipline * 5+ years of quality assurance and/or operation experience in pharmaceutical or biotech manufacturing environment. * You have ideally a first experience managing a team directly or indirectly. * You posses GxP knowledge of regulations. * You have Electronic Batch Record and elogbook management experience As Quality Assurance Supervisor, 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 work with the Quality Assurance Associates but in addition coordinate and manage *the activities and work of the team. Through your level of expertise you are able to drive *improvement projects. You will report to the Quality Assurance Manager 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 lead 3-5 QA colleagues.
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