Specialist Qa Compliance And Sterility Assurance 80

vor 2 Wochen

Köniz, Schweiz Bavarian Nordic Berna GmbH Vollzeit

as QA representative in multidisciplinary teams, to oversee the following topics:Deviation, Change Control, CAPA ManagementSterility Assurance and Contamination ControlProcess ValidationWhat is in the role for you:Reviews and approves deviations, investigations, CAPAs and Change ControlsReviews and approves process validation documents including risk assessmentsOversees site manufacturing activities (oral and parenteral) concerning sterility assuranceOwns the Contamination Control Strategy documents of the siteEstablishes annual Product Quality ReviewsEstablishes and approves trend reportsEnsures regulatory compliance and continuously improves the allocated quality systems and proceduresParticipates in audits and inspection within the area of responsibilityWhat do you bring to it:Master’s degree preferrably in Life Sciences or related field with track record in Microbiology and Sterility AssuranceMinimum of 5 years relevant experience in a GxP regulated pharmaceutical/biotechnology industrySolid computer skills including MS Office required / SAP, LIMS, Quality Management Systems skills are a plusAnalytical thinking and problem-solving attitudeMultilingual – at least German and English, written and spoken We provide an opportunity to be a part of an international company that boasts exceptional technology and a determined team. Join our dedicated and agile QA team if you share our enthusiasm and have a desire to create an impact. You can expect a vibrant and adaptable work environment that supports the growth of your personal and academic skills.

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