Quality Assurance Specialist for Manufacturing Processes

4 settimane fa


Ferentino, Lazio, Italia Thermo Fisher Scientific A tempo pieno
Job Summary

As a Quality Assurance Specialist for Manufacturing Processes at Thermo Fisher Scientific, you will play a vital role in ensuring the quality and integrity of our manufacturing processes. Your primary responsibility will be to evaluate and validate the cleaning and production processes to ensure compliance with regulatory requirements and company standards.

Key Responsibilities:
  • Evaluate manufacturing process documents and equipment cleaning procedures for validation purposes, ensuring compliance with regulatory requirements and company standards.
  • Develop and implement protocols for process validation, including Media Fill and cleaning validation, to ensure the quality and integrity of our products.
  • Collaborate with cross-functional teams to define protocol contents and actions to be carried out, ensuring seamless execution and compliance.
  • Validate manufacturing processes, cleaning procedures, and Media Fill to ensure accuracy and reliability.
  • Support the drafting and approval of documents for new product transfer and validation, ensuring compliance with regulatory requirements and company standards.
  • Ensure accurate execution of validation activities and detailed analysis of results, providing actionable recommendations for process improvements.
  • Draft validation reports and ensure proper archiving of all documentation, maintaining a record of all validation activities.

Requirements:
  • Bachelor's Degree or equivalent in a scientific or pharmaceutical area.
  • 2 years of previous related experience in the pharmaceutical sector, with a focus on quality assurance and process validation.
  • Knowledge of pharmaceutical techniques, production, and aseptic filling processes, with experience in risk management and client service/project management.
  • Proficiency in Microsoft Office software, with excellent written and oral communication skills in English.


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