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Archiviertes Projekt - Process Expert (m/f/d)

Firmenname für PREMIUM-Mitglieder sichtbar

  • Januar 2021
  • nicht angegeben
  • Stein
  • auf Anfrage
  • 13.01.2021
  • 518121/1-en


Ihre Aufgaben:
• Provide front line expertise for all process-specific issues to production within one or more production steps and equipment, to ensure execution of processes on-time
• Continuously improving in quality and efficiency, performed in compliance to cGMPs, SOPs, SHE and applicable guidelines
• Manufacturing Processes: Own and provide expertise to the assigned manufacturing process
and support the goal of executing each batch safely, in time, in compliance with the quality requirements
• Technical Transfers and Validation:  Execute and support technical transfer and (re-)validation projects incl. all relevant documentation  and implement and support scale-up activities of existing processes
• Technical improvements: Execute and support process improvement projects // Drive and support implementation of new technologies/equipment
• Investigations: Lead process related trouble shootings/investigations and deviation investigations // Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root
causes of product and process failures
• Audit support: Maintain the assigned processes/equipment at Inspection readiness level and provide the necessary support in any internal or external audit
• Batch record: Perform review of batch records

Ihre Qualifikationen:
• BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree / equivalent experience. Desirable MSc. or equivalent experience
• Profound experience in process support role on the shop floor of GMP manufacturing and/or QA/QC
• Proven process understanding with profound understanding of regulatory and cGMP requirements
• Lean Green Belt certification (preferred but not required)
• Proven process understanding in Sterile Manufacturing (Pharma, regulatory aspects)
• Familiarity with GMP requirements, quality procedures and SOP execution
• Good communication skills and interaction with a variety of interfaces within the organization and on the shop floor 
• Strong team orientation 
• Structured and proactive working attitude
• Self-driven and result-oriented
• Proven IT knowledge, knowledge in SAP or MES is an asset

Ihre Vorteile:
• Continuous support during the assignment
• Dynamic and innovative market environment
• Modern, perfectly equipped workplace

Projektdauer: 12 MM++

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