GMP Documentation Specialist
3 settimane fa
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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