Neyruz, Fribourg, Switzerland
11 years of quality assurance experience in the pharmaceutical industry
• Supports timely release of clinical Biologics (DS, sterile DP, and secondary packaged clinical supplies) • Manufacturing Batch Record Review of Biologics (DS, sterile DP, and secondary packaged clinical supplies) • Provides support to updates and review of Standard Operation Procedures and other GMP relevant documents • Serves as a point of contact for issue resolution. • Supports investigations and changes in related stakeholder areas • Supports equipment qualifications and computer system validations in related stakeholder areas • Conducts Walkthrough Audits and Internal Audits • Supports the Quality on the Floor program • Supports analytical method validations (incl. microbiological testing) for in-house and outsourced analytical testing • Tracks and monitors local operational and quality performance.
Support to the IMP QPL in following activities: • Responsibility for the lot disposition (release or reject) of Investigational Medicinal Products (API or bulk) and issuing the corresponding CoM, BC and CoA • Review and approval of the following documents: Master production records, batch production records, methods and specifications, definitions of storage and transport conditions, definitions of use-by date resp. retest date, change control documents, complaints and deviation records in Trackwise and finally the cleaning assessment reports • QA supervision of qualification and validation activities for GMP relevant equipment, production area, infrastructure, critical utilities (WFI, Gas, PFS-and Vial-filling line) and processes (e.g.Media Fills) • Preparation and participation in self-inspections and internal audits • End-to-end quality oversight (complete supply chain of the different projects)
• Patient recruitment • Collecting and managing the study data following SOPs • 2/6 months patient follow up by phone • Data cleaning