GMP Documentation Specialist

3 settimane fa


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

Job Summary:

The GMP Documentation Specialist will play a crucial role in ensuring that all documentation related to GMP compliance and quality assurance is accurately crafted, maintained, and managed.

Key Responsibilities:

  • Ensure GMP documentation is in compliance with regulatory requirements and internal quality standards.
  • Manage document revision processes, track changes, and maintain an audit trail of all SOP/Form/WI/JA versions.
  • Collaborate with cross-functional teams to create and review GMP documents, ensuring accuracy, transparency, and compliance with regulatory standards.
  • Support the Team Leader QA Training & Documentation in ensuring the compliance of the company with current quality regulations (laws, GMP, AIFA, FDA, etc.) normative.
  • Participate 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 with a strong understanding of Health authorities FDA and international regulatory requirements.
  • Excellent written and verbal communication skills.
  • Ability to work in a team and collaborate across different departments.

Preferred Qualifications:

  • Proficiency in document management software and Microsoft Office applications.
  • Strong attention to detail and excellent interpersonal skills.

Language: Italian and English.



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