Sr. Validation Specialist

Sr. 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.