ProPharma
ClinicalQualitySpecialist
“Clinical Quality Specialist at ProPharma. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. Supports the delivery or Clinical services, to assure ongoing compliance with quality and industry regulatory requirements. Performs improvement activities through continuous monitoring and evaluation of the quality system to ensure ongoing maintenance”
What You'll Achieve.
Assure ongoing compliance with quality and industry regulatory requirements; Ensure ongoing maintenance of the quality system; Identify areas for improvement in the quality system; Determine efficacy of CAPAs
Industry & Context.
Analytical skills to gather and interpret data; Must be able to identify trends and outliers
What They're Looking For.
Must Have
Minimum 2 years of experience working in a Quality Assurance role, Deviation, CAPA, Effectiveness Check handling experience
Nice to Have
Knowledge and experience in working with GxP Quality Management Systems including but not limited to record management, reporting, and data analytics
What You'll Do.
Supports the delivery or Clinical services
to assure ongoing compliance with quality and industry regulatory requirements
Performs improvement activities through continuous monitoring and evaluation of the quality system to ensure ongoing maintenance
Generates and prepares reports to communicate outcomes of quality activities
Analyzes and investigates Deviations and Quality Events to identify areas for improvement in the quality system
and communicates root cause and corrective action to stakeholders
and monitors corrective and preventive actions
and analysis of data related to CAPAs
Deviations and quality KPIs
and trends audit findings and response times
Supports external client audits or regulatory inspections by creating reports
and supplying requested data
Performs effectiveness checks on Deviations and Quality Events to determine efficacy of CAPAs
Supports and facilitates eQMS activities (i. e.
QA review and approvals
Change Control assessments
How You'll Work.
Team & Collaboration
Works in a professional manner with clients, team members and management; Reviews, approves, and communicates root cause and corrective action to stakeholders; Supports external client audits or regulatory inspections by creating reports, gathering documents, and supplying requested data
Communication Scope
Excellent written and verbal communication skills in providing feedback and identifying improvements where needed
Process & Methodology
Ability to prioritize and organize the tracking of data, documentation maintenance and record keeping
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