CRO Quality Specialist

CRO Quality Specialist 
Clinasia Labs Private Limited - Hyderabad, Andhra Pradesh

• quality needs and audits of the organization.
• Should have execute global consulting engagement.
• Should be able to handle client audits with ease.
• Should ensure the organization strictly adheres to quality in each of its process and daily work activities Good Knowledge of Clinical Trials Domain in FDA environment.
• Experienced Quality professional with an expertise of handling FDA regulatory compliance related to clinical trials domain.
• Should have past experience in successfully helping clinical research software product companies to achieve FDA compliance for their software products.
• Good Knowledge about all FDA guidelines such as 21 CFR Part 11, CDISC guidelines and other FDA regulations pertaining to clinical trials.
• Ability to do effective gap analysis visvis FDA requirements and steer the customer team to achieve the compliance successfully.
• SOP development for product delivery and Product realization. Process implementation.
• Conducting regular internal Audit for ensuring Process compliance with the regulatory standards.
• Training teams internally on SOPs.
• Audit facing and follow up.
• Corrective and Preventive Actions on identified deviations.
• Electronic Signatures and Electronic Records SOP draft and implementation.
• Conducting training on SOPs.
• Conducting Internal Audits.

For more info visit at mentioned link