Farah Yasin

Compliance Process & Training Manager at Roche

• Pakistan - Karachi
• October 2015 to November 2021

 Created quality and compliance excellence in clinical studies by embedding QMS principles in the processes and drive implementation of process improvement. It included gap analysis and as an outcome many new processes implemented to complement ICH GCP & regulatory requirements.
 Performed internal assessments, RCAs and proposed effective CAPAs which greatly reduced the reoccurrence & associated risks
 Implemented a training compliance plan to ensure that team members (Medical, Quality, Safety, regulatory and CRAs)s and investigators/sire staff receive training and refreshers in timely manner and always achieved >98% compliance metrics
 Ensured inspection readiness via random quality checks, internal assessments and generation of appropriate response plans
 Developed an internal process to execute compassionate use program