Quality Assurance Operations Specialist

4 settimane fa

Milano, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
Job Description

Job Title: Quality Assurance Operations Specialist

Job Summary:

Support the Quality Assurance Operations Team Leader in the evaluation of produced lots and the working environment, through the verification of documentation and other necessary information. Conduct investigations on GMP-related issues and deviations, and handle customer complaints in accordance with standards, company procedures, and regulations (laws, GMP regulations, FDA, etc.).

Key Responsibilities:

  • Preparation and release of commercial lots and conformity judgment
  • Support the Team Leader, the Qualified Person, and the Quality Operations Senior Manager in the release of product lots, through the formulation of a conformity judgment of the product to specifications based on documentary verifications, in accordance with regulations (laws, GMP regulations, FDA, etc.) and company quality standards.
  • Deviation management and investigation report
  • Conduct investigations on deviations from the production process to identify the root cause through documentary verification and close collaboration with support structures (production, maintenance, QC, Opex) in accordance with SOPs, regulations (laws, GMP regulations, FDA, etc.), and company quality standards.
  • Propose corrective and preventive actions to ensure effective closure of deviations in accordance with quality standards and company procedures.
  • Support the archiving and management of documentation related to batch records and deviations in accordance with the Quality System and company standards.
  • Customer complaint management
  • Conduct investigations on customer complaints through understanding the causes and identifying the most suitable corrective or preventive actions, leveraging the collaboration of support structures (production, maintenance, QC), to maximize customer satisfaction with the service received, in accordance with SOPs, regulations (laws, GMP regulations, CFR 21, FDA, etc.), and specific agreements with customers.
  • Audit support
  • Support the Team Leader in the preparation and management of customer and regulatory audits.

Requirements and Qualifications:

  • University degree in CTF, Pharmacy, Chemistry, Biology, or similar scientific disciplines
  • Experience in managing deviations related to production and control of pharmaceutical product production, preferably sterile
  • Deep knowledge of GMP/FDA regulations
  • Good written and spoken English skills
  • Ability to work in a team and excellent relational and organizational skills

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