Senior Scientific Expert, QA Support Functions

vor 2 Monaten

Bern, Schweiz CSL Behring AG Vollzeit

As a Senior Scientific Expert QASF, you will be performing routine and non-routine quality oversight activities in collaboration with the local Maintenance & Utilities, Quality Control, local warehousing, and internal transports teams. You will also be performing Quality on the Floor activities for the areas of responsibility. This includes operational quality management according to cGMP to assure appropriate quality of the services provided to the Value Streams, adherence to CSL standards and procedures, review, and approval of related complex GxP records, support and approval of quality risk assessments, non-conformances, investigations, CAPAs, change controls, while keeping awareness of the corresponding quality performance metrics. You will also be expected to participate in cross-functional projects. As a Senior Scientific Expert, you will be a Subject Matter Expert for deviations and changes during inspections and audits.

Your responsibilities, in detail, will include:

  • Partnering and influencing relevant stakeholders in maintenance, utilities engineering, quality control and local warehouse to maintain compliance and adhere to QA standards.
  • Provide Quality Assurance oversight and facilitate quality decisions jointly with the stakeholders in the areas of maintenance / utilities, utility monitoring, material management, warehousing, and quality control to maintain compliance in the specified areas.
  • Periodic quality oversight floor tours in warehouse with warehouse supervisor and Supply Chain for improvement and exception handling. Support introduction of new Quality on the Floor activities
  • Management of complex and cross-functional local deviations, isolating GMP-relevant key indices, performing initial risk assessments, Quality on the Floor oversight of the investigation, generating deviation reports, establishing root cause, and defining CAPAs, QA approval/closing of deviations, effective CAPAs and recurrence investigations support.
  • Expert for cross functional change management, manage complex minor, moderate and cross-functional change requests, QASF assessment of changes.
  • Review and completion of APR/PQR regarding raw material data. Review for trending and clusters for rejected lots.
  • Review and approve GxP documentation, including complex documents e.g. QA representative in team risk analyses.
  • Prepare and present quality investigations for minor and major deviations and minor and moderate changes to health authorities.

Qualifications and experience required for the position:

  • Master or Graduate university degree in relevant discipline (or equivalent)
  • 3+ years of experience working in a similar role.
  • Sound expertise in cGMP and compliance.
  • Material management and warehousing & logistics.
  • Quality control & analytical methods.
  • Experience in change control, deviation management, CAPA management.
  • Strong communication, collaboration and influencing skills
  • Fluent German and English
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