Qualified Person (m/f/o)

Tasks

• Oversee and actively participate in the batch release and certification process, ensuring that all required documentation is complete, accurate, and compliant prior to release
  
• Serve as the primary quality contact for assigned clients, addressing quality-related matters, deviations, and product complaints in a timely and compliant manner
  
• Perform review and approval of validation- and GMP-related documentation, including change controls, deviations/non-conformances, and CAPAs, ensuring appropriate risk assessment and regulatory impact evaluation
  
• Lead or support internal and external audits, as well as regulatory inspections including preparation, execution and follow-up activities
  
• Provide technical guidance and oversight to Quality, Production, Warehouse, and Supply Chain functions to ensure ongoing compliance with quality systems, procedures, and regulatory expectations
  
• Contribute as a site subject matter expert to local and global Quality initiatives, supporting projects, continuous improvement activities, and product launches , as required
  
• Perform additional QA-related activities within the Operations, Systems or Validation functions, aligned with business exigencies and the candidate's expertise

Requirements

• Tertiary-level degree in a relevant scientific discipline, meeting all criteria as defined under EC/2001/83
  
• Demonstrable experience performing QP duties within a GMP-regulated pharmaceutical manufacturing environment
  
• Strong problem-solving skills, including the ability to analyse quality issues, identify root causes, and propose and support effective, compliant solutions
  
• Pharmacist qualification and/or experience as a Responsible Person (RP) will be considered an asset.
  
• Communicating clearly and concisely, both orally and in writing across multiple levels of the organisation
  
• Proven ability to manage multiple priorities and assignments effectively in a regulated environment