Glp/gcp Quality Assurance Specialist
2 settimane fa
Aptuit, an Evotec company, is a worldwide Contract Research Organization, collaborating with all the major Pharma and Biotech companies in support of various drug discovery and development projects. To efficiently support ongoing activities and needs, we are looking for a highly motivated GLP/GCP Quality Assurance Specialist who is responsible for assuring the compliance with GLP/GCP principles.
Responsibilities:
- Perform protocol and amendments audit for compliance with GLP/GCP;
- Perform GLP/GCP raw data (paper & electronic) and report audits and issue quality assurance statement for inclusion in the final report;
- Perform, report and follow up critical phase, process and facility inspections;
- Maintain and archive QA files;
- Review and approve Standard Operating Procedures;
- Input/update information into the Master Schedule;
- Assist with the preparation for and hosting of client audits and/or regulatory inspections;
- Interact with internal and external clients to discuss QA observations and study-related issues, and maintain effective and professional working relationships within and across departments in relation to study projects;
- Participate and lead in the improvement initiatives intended to improve quality, compliance of study, project data and reports; effectiveness and efficiency of the processes;
- Detect quality issues and the need for CAPAs and assist Quality Assurance Management with the CAPA process;
- Assist or perform other job duties as assigned by Quality Assurance Management.
Requirements:
- Degree or PhD in Science fields (Biology, Biotechnology, Pharmaceutical Technology and Chemistry, Chemistry, or equivalent);
- At least 5 years experience in GLP/GCP Quality Assurance;
- Good written and spoken English is essential;
- Effective communication, both verbally and in written form, to Sponsors as well as members of internal teams;
- Able to quickly adapt to the ever changing landscape of Drug Development (accelerated technological changes, data analytics and new therapies);
- Use of quality metrics / KPIs to guarantee continuous improvement;
- Knowledge of Risk Management;
- Commitment to achieve the assigned deadlines;
- Good problem solving attitude;
- Knowledge of ATMPs and Computer System Validation is a plus.
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