Technical QA Manager (ROCGJP00026190)
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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