Senior Quality Assurance Expert
Há 7 dias
About the Role
We are looking for a Senior Quality Assurance Expert to join our clinical audits team. In this role, you will be responsible for ensuring compliance with regulations, guidelines, and operating procedures through the planning and conduct of independent clinical audits.
Your Key Responsibilities Will Include:
- Planning, scheduling, conducting, reporting, and closing audit activities in various countries involved with IQVIA contracts.
- Evaluating audit findings and preparing and distributing reports to operations staff, management, and customers.
- Providing interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
- Reviewing, approving investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA), and Effectiveness Check (EC) plans and tracking till closure for quality events arising from Audits.
- Evaluating policies and procedures for compliance with applicable regulations/guidelines and providing recommendations to management for continuous process improvements.
- Maintaining the electronic quality management system (eQMS) and providing support in relation to the audit lifecycle.
You Will Need:
- Bachelor's Degree Preferred.
- 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits. GCP experience.
- Experienced in the conduct of CSR/DM/BIOS clinical trial audits.
- Knowledge of word-processing, spreadsheet, and database applications.
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
- Knowledge of quality assurance processes and procedures.
- Strong interpersonal skills.
- Excellent problem solving, risk analysis, and negotiation skills.
- Strong training capabilities.
- Effective organization, communication, and team orientation skills.
- Ability to initiate assigned tasks and work independently.
- Ability to manage multiple projects.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
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