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
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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.
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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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