Quality Control Manager - Rimini - PQE Group

    PQE Group
    PQE Group Rimini

    1 settimana fa

    Default job background
    Servizi / Energia
    Descrizione

    Quality Control Manager

    PQE Group, a world leader in the Pharmaceutical and Medical Device industries, seeks a highly experienced Quality Control Manager to join a project for one of our most important clients based in Anagni.

    Main Responsibilities:

    • Lead daily activities in the QC laboratory to ensure efficient operations and high-quality results.
    • Manage lab processes and workflows, implementing continuous improvements to enhance productivity and compliance.
    • Coordinate analytical method transfers and validations for biotechnological products, focusing on peptides and recombinant proteins.
    • Provide technical guidance and oversight to QC teams, ensuring accurate test method execution and adherence to GMP standards.
    • Collaborate with R&D, QA, and Manufacturing to drive process alignment and support cross-functional projects.
    • Develop and review SOPs, protocols, CAPAs, deviations, and method transfer documentation to meet regulatory expectations.
    • Analyze root causes and support investigations using TrackWise.
    • Optimize resource allocation, manage laboratory scheduling, and mentor junior staff to foster their growth and development.
    • Select, train, and mentor a future QC Supervisor from the client's internal team to ensure seamless succession planning.

    About You:

    • 5–6 years of experience in Quality Control or Analytical Development within the pharmaceutical or biotech industry.
    • Minimum 2 years of experience in a supervisory or team leadership role (e.g., QC Manager, QC Supervisor, Assistant QC Manager).
    • Hands-on experience with techniques such as HPLC / UPLC, GC, LC-MS, UV-VIS, IR spectroscopy, KF titration, SDS-PAGE, etc.
    • Strong knowledge of method validation and transfer, especially under GMP and ICH guidelines.
    • Proficiency in lab software such as Empower 3, LIMS, TrackWise, and scientific instruments.
    • Skilled in team planning, performance monitoring, and lab process optimization.
    • Familiarity with Change Control, CAPA, deviation management, and data integrity best practices.
    • Excellent organizational, documentation, and communication skills.
    • Experience in project tracking, reporting, and technical problem solving.

    Key Skills:

    • Leadership and team management
    • Quality control and analytical development
    • Lab process optimization
    • Method validation and transfer
    • GMP and ICH compliance
    • LIMS and laboratory software
    • Scientific instrumentation and techniques
    • Project tracking and reporting

    Location:

    Anagni (Italy) - 100% onsite. Available to travel within Italy and Europe.

    Next Steps:

    Initial HR interview -> Technical interview with Hiring Manager -> Proposal discussions or further steps.



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