Technical QA Manager

vor 4 Wochen


Basel, Basel-Stadt, Schweiz Talentor Switzerland Vollzeit

General Information:

  • start date: asap
  • extension: possible
  • workplace: Basel
  • remote: on-site required, home office upon discussion
  • travel: no


Tasks & Responsibilities:

  • QA supervision of qualification- and validation-activities for GMP-relevant equipment (including CSV), Analytics, infrastructure, critical utilities (WFI, PW, Gas) and processes within PTD Basel
  • 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, 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 between sites
  • 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


Must Haves:

  • You have a Degree in Engineering, Chemistry, Life Science, Pharmacy or equivalent
  • You bring 5 or more years of related experience in the Pharmaceutical industry
  • First hands on 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
  • Fluent German and English (spoken/written) is a must for this position
  • Proven ability to work towards results, excellent planning and organizing skills in order to manage multiple tasks at the same tim

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