QC Support Compliance Senior Engineer

vor 2 Monaten


Corsiersurvevey, Schweiz Randstad Vollzeit

As a pivotal member of the organization, you will play a crucial role within a diverse team operating in a dynamic, global environment. Your responsibilities will include:

  • Acting as the primary compliance representative for the quality control department and QC Support Team
  • Taking the lead on deviations, CAPA, and periodic reviews associated with our activities
  • Providing expert training in CCP, CAPA, and investigations
  • Ensuring and overseeing compliance for the QC Support Group and the Quality Control Department
  • Contributing significantly to the continuous improvement of quality control support processes and procedures
  • Reviewing and approving internal documents and agreements
  • Participating in equipment and material qualification processes
  • Serving as a quality project manager to proactively identify and resolve issues
  • Collaborating extensively with various functions and stakeholders
  • Acting as an expert for deviation, change control, and CAPA topics during health authority inspections
  • Providing backup for other QC support compliance, autonomously resolving compliance issues promptly, contributing to continuous improvement using a lean process mindset, and actively participating in performance management meetings to drive improvement.

    Qualifikationen

    • Engineering degree in sciences (chemistry, biology) or a minimum of 3 years of experience in a GMP environment
    • Minimum of 1 year expertise in the biotech industry
    • Highly precise, rigorous, and detail-oriented
    • Exceptional team player with the ability to collaborate effectively across departments
    • Extensive experience in quality control and quality systems
    • Proficiency in planning tools is a plus
    • Good knowledge of visual management
    • Familiarity with applicable cGMPs
    • Fluency in French and English
    • Process-oriented with a strong customer service focus
    • Proficient in problem-solving tools and ensuring their use in the group
    • Results-driven with a "can do" attitude
    • Autonomous, reliable, and highly motivated
    • Positive and collaborative communication within the team and with partners/customers


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