Quality Systems Coordinator
7 giorni fa
We are looking for an experienced Quality Systems Coordinator to join our team at Philogen S.p.A. As a key member of our Quality Assurance department, you will play a critical role in supporting our Quality System and ensuring compliance with regulatory requirements.
Key Accountabilities- Coordinate the development, review, and approval of quality documents, including SOPs, PQRs, IMPDs, validation protocols and reports, technical reports, etc.
- Oversee the revision and maintenance of production and quality control batch records to ensure accuracy and completeness.
- Manage the GMP QA operations, change control, deviations, CAPA, and documentation systems to maintain a high level of quality and compliance.
- Work closely with cross-functional teams to identify areas for improvement and develop recommendations for process enhancements.
- Collaborate with stakeholders to implement action plans and ensure timely completion of projects.
- Conduct risk assessments and develop mitigation plans to minimize risks associated with product development and manufacturing.
The successful candidate will have:
- A minimum of five years of experience in Quality Assurance, with a deep understanding of GMP regulations and global quality standards.
- Excellent analytical and problem-solving skills, with the ability to prioritize tasks and manage multiple projects simultaneously.
- Strong communication and interpersonal skills, with the ability to work effectively in teams and communicate complex information to stakeholders.
- A high level of English language proficiency, both written and spoken.
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