QA Compliance Manager for Biologics.

Job ID: 10781

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Disziplin
Quality/Production
Stellenart
Project Consulting
Unternehmen

Our costumer is a global leading pharmaceutical company based in Basel, Switzerland.

Ihre Aufgaben
  • Supports project activities as member of QA Compliance for activities related to qualification / validation of equipment, utilities and facilities and associated change controls activities
    • Review and approve Process Validation Protocols and Reports (Revalidation, Verification, Product Transfers) including associated Risk Assessments and Deviations
    • Review and approve Cleaning Validation Protocols and Reports (Revalidation, Verification, Product Transfers) including associated Risk Assessments and Deviations
    • Review and approve Equipment, Facility and Utilities Qualification Protocols, Reports and associated documents including Risk Assessments and Deviations
    • Perform Quality risk assessments in case of critical deviations and initiate escalation process if applicable

  • Supports project activities as member of QA Compliance for activities related to Quality Management System
    • Writes / Reviews / Approves SOPs/Forms/reports associated with above duties and provide support for creation, maintenance and retirement of GMP related documentation in the respective databases (e.g. Sharepoint)
    • Prepares training modules for QA Compliance and C&GT Stein

  • Adheres to HSE guidelines and requirements
Ihr Anforderungsprofil
  • University or academic degree in Engineering, Chemistry, Pharmacy, Biology or equivalent.
    Language:
    Relevant Experiences: • Professional in German and English (spoken and written)
  • Professional experience in QA / QC, Engineering, Production
  • Very good GMP knowledge, experience of minimum 5 years in the pharmaceutical industry (sterile / biotechnology / C&GT a plus) or comparable experience in other industries
Region
Schweiz