Role Summary
The job holder is responsible for applying a local Quality Assurance program for the R&D Test Facility in alignment with Good Laboratory Practice (GLP), other applicable regulations and company best practices. This is to assure Test Facility Management (TFM) and management that the facilities and studies are in compliance with Good Laboratory Practice regulations.
Additionally, the incumbent supports the implementation of applicable standards pertinent to non-clinical research and/or toxicological assessments in order to verify that the studies are performed in accordance with the applicable regulatory frameworks, QMS requirements and best practices.
The incumbent also supports the quality oversight of suppliers and contract laboratories for pre-clinical research and/or toxicological assessments, as well as to identify opportunities for quality and process improvements in pre-clinical development.
Responsibilities
- Plan, perform and report QA inspections and suppliers audits to assure TFM and management that procedures/standards are in compliance with relevant national and international requirements for GLP for both internal and external entities. Monitor and follow up on corrective actions and preventive actions (CAPAs) reporting in response to internal audits and regulatory inspections.
- Support the monitoring of pre-clinical studies throughout their conduct and reporting for compliance with the GLP principles.
- Support R&D Test Facility for inspection readiness, participating in regulatory inspections/accreditations, and managing the corrective and preventive actions (CAPAs) reporting in response to internal audits and regulatory inspections
- Provide administrative support for the QMS document/record/training management system, including QA review of records such as QMS documents (SOPs/WKIs/Forms), Training, Nonconformance (NC), Corrective Action Preventive Action (CAPA) and Lab Change Request (LCR) for key QMS processes. Provide regular training on the systems and QMS (e.g. Good Documentation Practice, GLP) for new and existing staff.
- Manage the archival process in accordance with established SOP and GLP principles
- Monitor and report quality Key Performance Indicators (KPI) during Quality Management Review (QMR)
- Perform QA review of equipment/instrument qualification plans, reports and related documentation for GLP activities, to assure that the laboratory equipment/instrument are suitable for their intended purposes
- Continue to be developed as an expert in understanding GLP compliance on a global basis including local compliance enforcement experience with Health Authorities
Requirement
- Bachelor degree in scientific discipline (Life Sciences, Biology, Chemistry etc) or equivalent
- Minimum 3 years of work experience in a laboratory environment (chemical/biologic analyses) and participation in quality assurance related to activities in tobacco, food, pharmaceutical or similar industry and/or at least 3 years experience as a specialist in a relevant area of activity. Experience in another quality standards eg. ISO 17025 would be an advantage
- Working knowledge of OECD principles of Good Laboratory Practice, knowledge of other quality systems such as FDA GLP Principles, cGMP, ISO, GCP and AAALAC is an advantage
