What are the responsibilities and job description for the Senior Quality Specialist position at PAREXEL?
Execute validation efforts and provides expertise to ensure technology solution projects adhere to established standards and quality expectations. Supports activities to perform assessments on technology solution projects which are low, medium, or high regulatory risk systems to identify and mitigate risks and prevent quality concerns.
Execute monitoring and maintenance of oversight for the selection and implementation of technology solutions for quality management in support of delivery of products and services to customers.
Assists in providing guidance, consultation and overall expertise to project teams in support of clinical trial and / or validation activities through the applicable lifecycle. Supports others in overseeing, monitoring compliance status and activities to ensure compliant state for a project, business area or portfolio. Supports activities to identify requirements for key validation deliverables, including but not limited to validation planning, resource estimates, risk and impact assessments, summary reporting and Electronic Records / Electronic Signature regulations.
Custodian and leader of the Parexel Quality System. Acts and is recognized as an ambassador for quality across the business and with customers.
Supports Japan or Global audit / inspection hosts with planning, coordination and hosting of technology related Sponsor audits.