Technical QA Manager

vor 2 Wochen


BaselStadt, Schweiz Talentor Switzerland Vollzeit

Start date: As soon as possible


Duration: 1 year/possible extension


Workload: 100%


Location: Basel, on-site



Responsibilities:



  • QA supervision of qualification- and validation-activities for GMP-relevant equipment (including CSV), Analytics, infrastructure, critical utilities (WFI, PW, Gas) and processes within TR&D in Base
  • Support of implementation of DI requirements
    Review and approval of GMP relevant Documents like Plans, Reports, SOPs, Change Control, Discrepancy Management, CAPA (corrective action and preventive action), Risk Analysis
  • Assist management in regulatory inspections and performing internal as well as partner audits Ensure adherence to cGMP requirements and Roche policies and standards in technical development functions
  • Apply advanced theory, quality principles, expert judgment and cross functional expertise to address complex problems independently
  • Provide technical and quality assurance input to review and approval of manufacturing and Quality related documents as appropriate, Serve as a Subject Matter Expert (SME) in support of departmental functions and build partnerships and collaborate with stakeholders in other areas of the business to ensure success of the quality.
  • Leading of complex risk assessments Leading resolutions of quality issues and establish work priorities to meet targets and timelines
  • Creation and periodic review of quality agreements (QAGs) with contract organizations including quality agreements
  • Cost conscious working and optimization of processes. Ensure the efficient use of the available resources (staff, equipment, machinery, working spaces, materials).
  • Assistance is required in the introduction and training of new employees


Requirements:



  • Degree in Engineering, Chemistry, Life Science, Pharmacy or equivalent
  • Fluent German is mandatory
  • Min. 5 years of Quality Management related experience in the Pharmaceutical industr
  • Experience in Qualification/Validation and CSV of Small Molecules, Analytics and/or Biologics
  • Sound understanding on current DI (Data Integrity) requirements
  • Experience with MES (Manufacturing Execution System)
  • Profound knowledge of global quality and GMP requirements and a detailed understanding of current industrial trends in IMP

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