Freelance Consultant Quality Systems and Compliance (m/f/x)
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Basel, Schweiz |
Freelance
Job title: Freelance Consultant Quality Systems and Compliance (m/f/x)
Industry: BiotechSkills: QMS, Compliance, Global Quality
Start of project: 01.09.2023
Duration of the project : 9 months
Tasks:
Consult in designing a global QMS strategy involving relevant stakeholders to define a best in class endpoint
Ensure consistency of the document framework (guidance documents, standards, SOPs)
Tailor the global system framework to the endpoint of a highly efficient, best in class newly built facility
Leverage Network / Benchmark Learnings and apply to the newly built Facility QA Approach, for e.g among others award best in class practices (Raykoon Steel with Pride)
Consult project teams to ensure processes are fully aligned with current standards and regulations
Providing guidance, expertise and coaching, assisting sites and their teams for policies, procedures and specifications
Act as a Coach / Consultant to ensure talent development
Qualifications:
Academical degree (Bachelor or higher) in Life Sciences
Substantial working experience in GMP manufacturing and Quality Management Systems of products regulated by FDA CBER or CDER or EMA
Substantial leadership experience
Lean Six Sigma Experience (Green/Black Belt Preferred), ability to design data driven Governance Systems
Experience in aseptic processing/sterile manufacturing
Fluency in English, German is an asset
Referenznummer: 13376
Branche: Biotech
Beginn des Projekts: Ab sofort
Dauer: 9 months
Anstellungsart: Freelance
Kontakt
Lars Uhl