Quality Assurance Specialist for Process Validation

2 settimane fa


Ferentino, Lazio, Italia Thermo Fisher Scientific A tempo pieno

Key Responsibilities:

  • Evaluate manufacturing process documents and equipment cleaning procedures to ensure compliance with validation requirements.
  • Develop and implement validation protocols for product manufacturing and aseptic filling, ensuring adherence to regulatory and quality standards.
  • Perform thorough cleaning validation of cleaning procedures and ensure periodic cleaning verification to maintain a high level of cleanliness.
  • Manage and coordinate validation protocols for cleaning, process, and Media Fill, ensuring seamless execution and documentation.
  • Collaborate with cross-functional teams to define protocol contents and actions to be carried out, fostering a culture of quality and collaboration.
  • Validate manufacturing processes, cleaning procedures, and APS/Media Fill, ensuring accuracy and precision.
  • Support the development and approval of documents for new product transfer and validation, ensuring regulatory compliance.
  • Handle deviations related to validation activities, implementing corrective actions to maintain quality standards.
  • Ensure accurate execution of validation activities and detailed analysis of results, providing actionable insights for process improvements.
  • Draft validation reports and ensure proper archiving of all documentation, maintaining a comprehensive record of validation activities.
  • Provide quality support for new product transfer and process qualification, ensuring seamless integration into our quality management system.

Requirements:

  • Bachelor's Degree or equivalent in a scientific/pharmaceutical area.
  • 2 years of previous related experience in the pharmaceutical sector.
  • Knowledge of pharmaceutical techniques, production, and aseptic filling processes.
  • Experience in risk management and client service/project management.
  • Proficiency in Microsoft Office software.
  • Fluent in English with advanced written and oral communication skills.


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