Qualification Engineer

Contenuto del lavoro

• Define, implement and maintain the qualification system in line with cGMPs, 21 CFR Part 11 and GAMP5. This include equipment, utilities, HVAC, PLCs and software qualification
  
• Apply and implement qualification SOP, related Corporate and ICH guidelines
  
• Ensure qualification status for all GxPs systems
  
• Propose and establish qualification strategy based on risk assessment for new or modified system
  
• Write, related qualification protocols and reports, coordinate and execute qualification
  
• Participate in assessment and execution of Change Control, Deviation and CAPA
  
• Timely follow-up of deviations, CAPAs and CCs in collaboration with the production and other departments
  
• Active participation during Inspection and Customers Audits (incl. preparation)
  
• Participate and propose improvement to SOP qualification review with QA qualification responsible
  

• University degree in relevant scientific/technical discipline
  
• At least 5 years experience in qualification in the pharmaceutical industry
  
• Strong understanding of cGMPs
  
• Good knowledge in Regulatory requirements
  
• Good knowledge of manufacturing and packaging operations
  
• Autonomy in the daily business
  
• Strong experience in Pharmaceutical field
  
• Good verbal communication and communication skills (incl. English)
  
• Able to make quality decision on time