Clinical Quality Assurance Manager
11 ore fa
Philogen S.p.A. is seeking a highly skilled Clinical Quality Assurance Manager (GCP) to join our Clinical Department. As a key member of our team, you will be responsible for ensuring the quality and compliance of our clinical trials in Europe and the US.
Key Responsibilities:- Maintain GCP/ICH compliant systems and processes to ensure the quality of work and clinical trials.
- Develop and review clinical SOPs and support continuous process improvements.
- Manage training of staff on company procedures, GCP regulations, and documentation systems.
- Qualify CRO and other vendors related to clinical activity.
- Perform documentation control in the TMF and quality reviews of clinical trial essential documents.
- Perform routine internal System and TMF audits and checks to ensure compliance with internal procedures and regulatory guidelines.
- Report significant clinical quality deficiencies and/or risks to upper management and actively participate in solving the issues.
- Lead role to prepare company and clinical sites for customer audits and regulatory GCP inspections.
- Good scientific background (ideally Master/PhD in Biology, Biotechnology, Life Sciences, etc.).
- 3-5 years of experience in Clinical Quality oversight (clinical QA experience in the pharmaceutical industry required).
- Complete understanding and application of principles, concepts, and practices of clinical research procedures.
- High level of English language, both written and spoken.
- High level of attention to detail.
- Ability to work independently and prioritize tasks and coordinate with team members.
- Excellent interpersonal skills and ability to work in teams.
Interested candidates are kindly asked to send their Curriculum Vitae to the specified email address, authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).
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Siena, Toscana, Italia Philogen A tempo pieno{"h1": "GMP Quality Assurance Specialist", "p": "Philogen S.p.A. is seeking a highly skilled GMP Quality Assurance Specialist to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality of our products and processes, while also contributing to the development of our quality policies and...
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