Senior Quality Systems Manager
Há 5 dias
Overview
TN Portugal is a leading organization in the industry, and we are seeking a highly skilled Senior Quality Systems Manager to join our team.
- The ideal candidate will have a degree in Pharmacy, Life Sciences, Chemistry, or a related field, with relevant experience in quality management systems.
About the Role
We are looking for a talented individual to maintain and continually update the Global Document System to ensure it aligns with all EU operating authorizations and licenses.
- The successful candidate will implement and oversee external document and process change control procedures to ensure seamless integration of updates.
Responsibilities
The Senior Quality Systems Manager will be responsible for ensuring compliance with GxP guidelines, including GMP, GDP, GCP, and GLP standards.
- This involves conducting audits of contracting companies, suppliers, and service providers worldwide, ensuring compliance with GMP and GDP regulations.
You Will Be Responsible For:
- Maintaining and enhancing the CAPA (Corrective and Preventive Actions) system to address quality issues and prevent recurrence.
Requirements
- A solid understanding of GxP guidelines, including GMP, GDP, GCP, and GLP, to ensure compliance with regulatory standards.
Additional Responsibilities
- Overseeing the audit process, including planning, execution, and support, to ensure all audits are completed effectively and within set timelines.
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