Senior Software Tester, Manual
iHorizons
TFS
Associate Director, Quality Assurance, GCP Auditor
TFS HealthScience
contract
Posted on:
Origin: • 🇵🇱 Poland
Visit company websiteJob Level
Senior
Tech Stack
TFS
About the role
- Ensure the Annual Audit Plan is prepared, followed and maintained along with the Audit Progress Report and tracking of all audit types
- Prepare, conduct and follow up on all types of internal and external GxP audits
- Support and guide operational staff in preparing for customer audits and inspections and host/facilitate customer audits
- Review and approve audit reports for other quality management personnel and act as Quality Lead Auditor when applicable
- Assist in preparing investigational sites and TFS for regulatory inspections; provide inspection readiness strategy and manage teams during inspections
- Oversight, management and support of Quality Issues including review and approval of Risk Reviews, CAPA and effectiveness verification
- Oversight and management of Complaints, Potential Serious Breach and Potential Fraud and Scientific Misconduct investigations
- Contribute to development and continuous improvement of the TFS Quality Management System and related QMS documents
- Provide quality management advice and support to internal staff, departments and external clients; host Quality Committees
- Ensure all GxP vendors are assessed and work with Vendor Management to resolve issues
- Responsible for audit metrics and assisting with Quality Management metrics
- Assist with proposals, costings and business development activities; review MSAs/Quality Agreements and manage RFIs/RFPs
- Act as trainer for Quality Management and TFS staff; prepare and distribute the Regulatory Intelligence Newsletter quarterly
- Maintain required knowledge of applicable regulations and company GxP standards and procedures
- Participate in internal meetings and perform other tasks delegated by Senior Director Quality Management within scope of experience
Requirements
- University/college degree or equivalent industry experience
- Awareness of global and local industry trends, government policies and regulations in the clinical trials and pharmacovigilance area
- In depth knowledge of GxP (including CSV) regulations and guidance
- Previous auditing experience is required, with thorough knowledge of requirements for GxP compliance
- Knowledge on GxP regulated computerized system validation activities and principles
- Previous audit management experience
- Good computer skills (Microsoft Word and Excel)
- Ability to work independently and efficiently
- Good planning, organisation and problem-solving abilities
- Fluent in English, both written and verbal
- Several years’ experience in clinical research (e.g. monitoring, data management, drug safety, training, etc.)
- Five to ten years’ experience of auditing in two to three GxP areas
- International travel to audit sites, worldwide
- Membership of a quality association (e.g. the Research Quality Association) is considered as an advantage
- For candidates based in Italy - compliant with the Italian MoH Decree dated on 15th November 2011 (G.U. n°11 dated on 14th January 2012)
- Applications welcome from candidates belonging to protected categories under art. 1 L. 68/99
