Operation analyst Jobs in Gladenbach
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Operation analyst • gladenbach
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Head of Compliance (m / w / d) - Deviation Management
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Central ParkingHessen, DEHead of Compliance (m / w / d) - Deviation Management
CSL BehringMarburg, Hessen, GermanyFor our Value Stream Filling / Lyophilisation in Marburg we are currently looking for a
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Head of Compliance (m / f / x)
Deviation Management
R-252602
Fulltime / permanent
The job incumbent is a key player in the Value Stream both for critical deviation investigations as well as in internal, customer and regulatory audits. The main responsibility of the role is to proactively drive and improve cGMP compliance and a best in class Right First Time (RFT) approach (deviation and CAPA management, data trending and analysis, training, SOPs, change control) within the respective Value Stream. The role might act as Compliance representative / SME on behalf of the Value Stream in projects or other initiatives. The compliance to relevant Global Quality Policies should be ensured while the respective SOPs and / or working instructions are continuously monitored to be well compliant, if necessary to be revised accordingly.
Tasks & Responsibilities :
- Strong leadership while motivating, developing and leading the team according to CSL values and principles.
- Leading and developing a team of approx. 12 motivated and qualified team members
- Coordination of complex deviations, identifying correct root causes (RC) and smart, effective CAPAs to avoid any re-occurrence of deviations. Compilation of deviation reports and risk assessments ready to be approved by QA.
- Performing data analysis and trending as a tool to identify potential compliance / process issues (e.g. IPC warning limits excursions, drop in yields) in a proactive manner, as a tool to identify potential opportunities for process improvements and / or to understand root causes of more complex compliance / process issues to initiate an appropriate remediation.
- Ensuring optimal inspection readiness in the Value Stream Fill. Preparation, successful conduct and follow-up of regulatory inspections, self inspections and customer audits as required
- Maintaining GMP training and adequate training status to ensure a compliant production (cGMP, EHS)
- Might act as compliance representative / SME on behalf of the Value Stream in projects or other initiatives.
- Initiate, coordinate and / or assessment of change controls. Ensure a compliant RTO (release to operation).
- Approval of production protocols according to §14 AMG (German Medicines Act)
Education & Requirements :
Was wir bieten
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Über CSL Behring
CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über CSL Behring.
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About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
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