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QA Validation Specialist

Geleen, Netherlands
Netherlands, Geleen

QA Validation Specialist reviews and approves documentation and oversees qualification and validation deliverables, associated with equipment, facility and utilities.

He/she reviews and approves validation documents and procedures associated with equipment, facility and utility operation, cleaning and maintenance.

He/she assures the deviations and changes are well documented and applicable corrective actions and systemic solutions are applied.

  • Main responsibilities are:
    • Overseeing validation and qualification deliverables:
    • Review and approve URSs;
    • Review and approve qualification and validation plans;
    • Review and approve validation documentation associated with equipment, facilities and utilities (DQ, IQ, OQ, PQ);
    • Review and approve the risk assessment related to equipment, facilities and utilities;
    • Review and approve the commissioning protocols and reports;
    • Review and approve FAT/SAT documentation;
    • Assure requirements traceability throughout the whole project validation file (from URS to PQ).
  • Overseeing validation life cycle documentation:
    • Review and approve equipment, facility and utility life cycle documents;
    • Ensure the correct application of the validation quality systems on the field and to define improvement plan;
      • Understanding of cGMPs, GAMP, ICH Q7A and validation practices (IQ/OQ/PQ) and their application in practice.
      • Conducting periodic review of validated GxP equipment, facility and utilities.
      • Performing validation impact assessments prior to implementation of changes on equipment, facility or utilities.
      • Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs and all aspects of safe, reliable and consistent operation of the system.
      • Support the production & technical services teams in the implementation of the validation activities.
      • Ensure the adequate management of validation deviations (be QA GMP Responsible) and potentials CAPA (be Compliance Authority).
      • Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.
  • Key Requirements:
    • Bachelor’s degree in scientific or technical field ( minimum )
    • 3+ years of experience in validation activities in a pharmaceutical or biotech manufacturing environment ( preferable )
    • Strong understanding of regulatory requirements and industry standards (FDA, EMA, ICH, etc.)
    • Strong communication and teamwork
    • Attention to detail and problem-solving abilities.
Reference: R60484

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