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Job summary
Join CSL Behring as a Data Integrity QA Site Lead at our Bern site. This role offers a collaborative work environment with growth opportunities.
Tasks
Advise the site on Data Integrity topics and standards.
Support the Global DI Program, ensuring alignment and planning.
Act as a Subject Matter Expert during inspections and audits.
Skills
University degree in a relevant scientific discipline required.
5+ years of experience in Data Integrity in the pharmaceutical industry.
Fluent in German and English, with strong teamwork skills.
Is this helpful?
We are looking for a Data Integrity QA Site Lead to join our team at CSL Behring Bern site. Partnering closely with the Global Data Integrity Business Process Owner and other Quality functions to continuously improve and standardize the DI processes and standards across the network of responsibility.
Responsibilities:
Advice and support site in Data Integrity related topics
Support of the Global DI Program (e.g by supporting internal planning and alignment)
Represent the Site Quality Assurance department as Subject Matter Expert in Data Integrity (responds e. g. to authority questions during inspections)
Manage the Site DI Quality Master Plan for execution at the local level
Lead local Data Integrity Steering Committee
Liaise with the Global Core DI Team on relevant topics
Qualifications:
University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
5+ years or more in the field of DI in the pharmaceutical industry
Profound Data Integrity background, including knowledge of relevant standards e.g.:
Regulations and guidelines (21 CFR Part 11, EU Annex 11, PIC/S GMP Guide Annex 11, ICH Q9,Q10)
Industry standards (GAMP 5 including DI related Good Practice Guides)
Authority expectations on Data Integrity culture and implementation of standards (PI 041-1, MHRA GXP’ Data Integrity Guidance and Definitions; FDA: Data Integrity and Compliance with CGMP Guidance for Industr
Experience within a global matrix organization
Strog teamwork and communication skills
Knowledge of current Good Manufacturing Practices (cGMP) principle
Experience in project management
Languages: Fluent German and English required
Experience in project management
Preferred experience working with CSV Technology and a fundamental understanding of IT concepts.
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.
CSL Behring is committed to provide equal employment opportunity for all.
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.
CSL soll so vielfältig sein wie die Welt, in der wir leben
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