GMP Documentation Specialist

4 settimane fa


Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
Job Title: GMP Documentation Specialist

Thermo Fisher Scientific is seeking a highly skilled GMP Documentation Specialist to join our team. As a key member of our quality assurance team, you will play a crucial role in ensuring the accuracy and compliance of our GMP documentation.

Key Responsibilities:
  • Develop and maintain GMP documentation in accordance with regulatory requirements and internal quality standards.
  • Collaborate with cross-functional teams to create and review GMP documents, ensuring accuracy, transparency, and compliance with regulatory standards.
  • Manage document revision processes, track changes, and maintain an audit trail of all SOP/Form/WI/JA versions.
  • Support quality operations teams to facilitate investigations, root cause analysis, and corrective and preventive actions (CAPA) related to documentation issues.
  • Assist in internal and external audits by providing accurate and organized documentation for inspection.
Requirements:
  • Master's degree in Chemistry, CTF, Pharmacy, or Biology, or at least 3 years of experience in a pharmaceutical company in a similar role.
  • Knowledge of GMP principles, regulations, guidelines, and international regulatory requirements.
  • Excellent written and verbal communication skills, with proficiency in document management software and Microsoft Office applications.
What We Offer:
  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.


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