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About Accelera

Accelera is a Preclinical CRO (Contract Research Organization) and offers unparalleled expertise in bringing innovative drug candidates from the Discovery to the Clinical Phases.

Over the years, Accelera has brought new products and innovative therapies to the market, supporting overall more than 300 Companies and Sponsors worldwide.

Accelera operates in strict compliance with the International recognized quality standards (Good Laboratory Practices), to ensure the smoothest development of innovative therapies intended to improve the quality of life of patients worldwide.

Job Function Tasks

The main function in this position is supporting the Quality Assurance Unit in conducting the audits on studies and activities performed in compliance with Good Laboratory Practice (GLP) Principles and CSV.

Main responsibilities are:

• Study document revision
• Conducting and reporting: 1. study phase and process inspections; 2. facility/suppliers inspections
• Periodic revision of the internal Standard Procedures (SOPs)
• Monitoring Computer Validated System to ensure full compliance with actual GLP regulations

Required Qualification

• Bachelor’s degree in Life Science or equivalent
• Ability to work flexibly and autonomously
• Experience in Regulatory Affairs and/or Quality Assurance unit is a plus.
• Solid understanding of contemporary quality practices as they apply to pre-clinical development operations
• Fluent in English