Quality Assurance Specialist for Quality Control (m/f/d)

Your Profile:

• Scientific background (e.g. Master's degree in a scientific discipline).
  
• Minimum 2 years of experience in Quality Assurance within the pharmaceutical or GMP-regulated environment.
  
• Strong knowledge of GMP guidelines and hands-on experience with quality processes and risk management.
  
• Excellent communication and collaboration skills with cross-functional stakeholders.
  
• Detail-oriented, solution-focused team player with a proactive mindset.

Your Tasks:

• Increase the visibility and strategic importance of Quality Assurance across the company.
  
• Maintain, develop, and continuously improve the Quality Management System.
  
• Ensure compliance with current pharmaceutical regulations, GMP guidelines, and internal procedures.
  
• Promote quality awareness and provide guidance on quality systems and requirements.
  
• Ensure inspection readiness and actively support internal and external audits.
  
• Investigate, manage, and resolve quality issues, including deviations, OOS, CAPAs, and change controls.
  
• Review and approve SOPs, laboratory investigations, and continuous improvement initiatives.
  
• Review and approve analytical method validations/verifications and equipment qualifications.
  
• Monitor regulatory requirements and ensure implementation of relevant laws and guidelines.
  
• Strengthen cross-functional collaboration and report critical quality issues to management.

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