Quality Specialist I

2 giorni fa

Verona, Italia Evotec A tempo pieno

Evotec is a life science company with a unique business model focused on delivering highly effective new therapeutics to the patients. The Company leverages its multimodality platform, the “Data-driven R&D Autobahn to Cures”, for proprietary projects and within a network of partners including Pharma, Biotech, academics, and other healthcare stakeholders. With more than 4,200 highly qualified people at 16 sites, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics. For additional information please go to

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- QA Rep supports all GMP projects working closely with the clients and project teams
- QA Rep provides a service across Aptuit sites to ensure project goals maintaining compliance to applicable GMP regulations and company standards. This includes:

- Agree a quality technical agreement for every project with GMP activities
- Drive quality and compliance through direct representation on projects
- Support investigation analysis and identify major GMP risks and drive mitigating or remedial action
- Perform review and approval or reject of Certificates of Analysis
- Perform review and approval of API pre-executed Batch Records for human use
- Perform review and approval of Drug Product Master Batch Records (bulk, primary and seconday packed) for human use
- Perform review and approval or reject of API and Drug Product Batch Records (bulk, primary and seconday packed) for human use
- Promote and maintain a high level of GMP awareness and compliance in the GMP areas
- Ensure records (paper and electronic) are properly filed, secured, and controlled and easily retrievable in the quality department in accordance with data Integrity expectation
- Review related quality records for completeness and accuracy
- Maintain relevant quality logs and track quality metrics as needed
- Perform other related duties as assigned
- Promote and maintain a high level of GMP awareness and compliance in the GMP areas
- Maintain good knowledge and understanding of Pharmaceutical and Chemical Development processes, and relevant regulations

**Requirements**:

- Scientific or technical high school graduation. Bachelor’s degree in Life Sciences or related scientific discipline will be considered as a plus.
- Good knowledge of English (written and orall)

Personal Skills
- Collaborative attitude oriented to problem solving;
- Good verbal, written, and interpersonal communication skills;
- Ability to multitask and easily prioritize work.

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