Biogen B

Quality Assurance Associate, Manufacturing (BB-E326F)

Gefunden in: Xpatjobs CH

Job Description

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 andtesting

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 andapprove Standard Operating Procedures (SOP)review, revision approval.

5. You collect data for metrics and identification of negative trends and you support the QAand regulatory affairs units with audits andinspections.

  • You have afirst solid experience in a Quality Assurance position within a manufacturing environmentin apharmaceutical, biotech or medical device industry.
  • You posses GxP knowledge of regulations.
  • You have ideally Electronic Batch Record and elogbook management experience

Additional Information

As Quality Assurance Associate, Manufacturingyou are responsible that all operations meet or exceed cGMP regulations on the manufacturing field. You collaborate with thedaily manufacturing- andfacility operations from a quality perspective, facilitatingactivities 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 tooffer; reactive support ofdiscrepancy 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-functionalwith 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.

calendar_todayvor 4 Tagen


location_on Luterbach , Canton of Solothurn, Schweiz

work Biogen

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