clinical quality assurance consultant
il y a 3 jours
Start: ASAP
Contract Length: 6 months
time on site: 2-3 days a week
Key Responsibilities and Tasks Clinical Study QA Representative
• Act as QA representative for assigned clinical studies to ensure compliance with Good Clinical Practices (GCP) and regulatory requirements.
• Provide timely quality-related guidance to study teams and participate in project meetings.
• Contribute to the selection and quality oversight of service providers.
• Escalate issues requiring additional support to QA Therapeutic Area (TA) Leads. Quality Management System (QMS) Activities
• Quality Events and Serious Breaches: Review and approve major/critical quality events and potential serious breaches.
• Corrective and Preventive Actions (CAPA): o Support root cause and risk analysis for clinical research issues. o Track CAPA activities to ensure timely completion and assess their effectiveness. o Monitor CAPA effectiveness, escalate delays or ineffectiveness, and foster a culture of process improvement. Quality Documents
• Contribute to the creation, review, and continuous improvement of R&D quality documents. Audits and Inspections
• Support inspection readiness activities for high-risk studies, including mock inspections and quality assessments.
• Oversee quality control of study documents and coordinate meetings with subject matter experts (SMEs) to manage inspection preparation.
• Monitor risks and remediation actions during inspection preparation, providing regular updates to QA TA Leads.
• Assist in inspection conduct and audit activities, supporting root cause analysis and CAPA definition for identified observations. Training
• Act as a subject matter expert (SME) for training sessions and review training materials as required.
• Ensure system users are adequately trained for clinical research activities, liaising with trainers and process owners to develop appropriate materials. Quality Objectives
• Collaborate with QA TA Leads to continuously improve clinical quality activities and achieve defined R&D quality objectives.
Experience and Qualifications Minimum Requirements:
• Education: Bachelor’s degree in a related field.
• Experience: Minimum of 5 years in Quality Assurance within the pharmaceutical industry, focusing on quality system management, preferably in Research and Development.
• Language: Fluency in English
. Preferred Qualifications: • Corporate-level QA experience in Research and Development is highly desirable.
Key Competencies: • Strong organizational and management skills, with the ability to prioritize tasks effectively. • Excellent communication and interpersonal skills, capable of influencing and engaging stakeholders. • Demonstrated ability to work collaboratively within a matrix organization. • Team player with high attention to detail and a commitment to producing high-quality work under tight deadlines
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