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Product Quality Responsible

FRESENIUS KABI · Beni Khalled

🇬🇧 English
ISO 9001 ISO 13485 GMP CAPA audit validation qualification batch documentation

Description du poste

About the role

The Product Quality Responsible will ensure that all manufacturing activities meet the highest quality standards in accordance with GMP, ISO 9001 and ISO 13485 requirements. Working closely with production teams in both the Beni Khalled and Blonie sites, the role drives continuous improvement, manages corrective actions and supports the launch of new products.

Key responsibilities

  • Supervise production‑related documentation, including batch records and control documents.
  • Oversee control, testing and research activities to eliminate quality errors during production.
  • Lead validation projects for manufacturing processes and equipment, and participate in qualification activities.
  • Coordinate product transfers between Blonie and Bir Drassen sites.
  • Train and mentor subordinate personnel on quality procedures.
  • Collaborate with the Production Department across sites to ensure seamless operations.
  • Lead CAPA investigations and manage non‑conformities related to production.
  • Control changes, handle incompatible materials, and ensure proper documentation of all actions.
  • Perform internal audits and support external audit activities.
  • Develop, review and maintain quality procedures, instructions and records.
  • Identify quality deviations, initiate CAPA activities and verify their effectiveness.
  • Ensure compliance with corporate, GMP and hygiene standards throughout the plant.
  • Manage raw material, semi‑finished and finished product controls, including measurement method validation.
  • Maintain accurate record‑keeping and supervise test execution for all product stages.

Required profile

    Required skills

    • ISO 9001
    • ISO 13485
    • Good Manufacturing Practice (GMP)
    • CAPA management
    • Audit execution
    • Validation and qualification processes
    • Batch documentation control
    • Measurement method verification

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    FRESENIUS KABI

    Beni Khalled