About Accelera
Accelera is a Preclinical CRO and offers unparalleled expertise in bringing innovative drug candidates from Discovery to Clinical Phases.
With over 300 clients worldwide, Accelera has brought new products and therapies to the market by supporting them with innovative solutions.
As a trusted partner, Accelera operates under strict compliance with International quality standards (Good Laboratory Practices) to ensure the smoothest development of innovative therapies that improve patient lives worldwide.
Job Function Tasks
The main responsibility in this position is supporting the Quality Assurance Unit in conducting audits on studies and activities performed in accordance with Good Laboratory Practice (GLP) Principles and CSV.
* Study document revision and updates
* Conducting and reporting phase and process inspections, facility/suppliers inspections, and study assessments
* Periodic review and update of internal Standard Procedures (SOPs)
* Monitoring Computer Validated Systems to ensure full compliance with GLP regulations
Required Qualifications
* Bachelor's degree in Life Science or equivalent qualification
* Able to work flexibly and autonomously
* Experience in Regulatory Affairs and/or Quality Assurance is an advantage
* Solid understanding of contemporary quality practices applied to pre-clinical development operations
* Fluent in English language