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Scientist, Engineer as QA Compliance Manager - Shopfloor (m/f)

QA Compliance Manager Shopfloor (m/f) Quality Unit, Biopharmaceuticals, Sandoz GmbH Kundl

Area of Responsibility

  • Responsible for shopfloor compliance in the manufacturing area
  • Perform checks during production so issues can be identified early (e.g. SOP ’ s followed, AQL, line clearance, IPC, batch records etc.)
  • I dentify areas for improvement of Shopfloor Compliance and provides input to process setup and improvement
  • Responsible for audit readiness of the production facility as well as preparation of shopfloor associates for audits
  • Auditor tour guide during inspections and required to participate in front room discussions with auditors
  • Actively Participate and lead root cause investigations ( “QA First Responder” for deviations)
  • Participate in out- of- specification (OOS) investigations, change requests and corrective and preventive actions (CAPA)
  • Work on initiatives to reduce human error and participate in creation of shopfloor training plans
  • Establishment & delivery of shopfloor communication strategy (QA, Production, Safety, KPI’ s, etc.) to ensure transparent information flow from Shopfloor to Management and vice versa

Qualifications

  • Education: completed scientific / technical studies (chemistry, microbiology, process engineering, biotechnology) or equivalent professional years experience
  • Languages: fluent in English and German
  • Experience: 5 years of experience in GMP Areas, experience in the field of API and FDF production or QA, experience from Health Authority and / or customer audits, expertise in GMP (sterile, non- sterile)
Our salary packages are competitive and take individual qualifications and experience into consideration. Moreover we offer attractive fringe benefits (e.g. profit sharing for all employees, modern company pension, childcare facility, training possibilities and global career opportunities). In accordance with the Austrian collective labour agreement, we advise you that the minimum gross annual salary for this role is 50,362.76 euros.
Contact: Cornelia Walch, Staffing Manager
Job-ID: 186153BR
Sandoz is an equal opportunity employer
Bitte beziehen Sie sich bei Ihrer Bewerbung auf jobvector und geben Sie die folgende Referenznummer an: 186153BR

Über Sandoz GmbH

Sandoz ist eines der größten Pharmaunternehmen Österreichs mit über 4000 Mitarbeitern. Als Teil der weltweiten Novartis Gruppe entwickeln, fertigen und vermarkten wir patentfreie Arzneimittel vor allem Antibiotika, injizierbare Krebsmedikamente und innovative Biosimilars. Mit unseren Arzneimitteln verbessern wir die Lebensqualität von Patienten in aller Welt....

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