Preclinical QA Specialist

Contract Type: Permanent

Closing date:
Reference: VN1817
- Who we are

Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems. We are driven by the exciting and unique goal of addressing unmet patient and consumer needs by revitalizing, repurposing, and reimagining existing therapies to better serve people in taking care of their health and wellbeing.

Role Summary

In this role you will be responsible for aligning our R&D Test Facility with Good Laboratory Practice (GLP), ensuring that all facilities and studies are in compliant.

You will support the implementation of ISO 17025 and other standards pertinent to non-clinical research, to ensure they meet applicable regulatory frameworks, QMS requirements and best practices.

Your role will also support the quality oversight of suppliers and contract laboratories for pre-clinical research and/or toxicological assessments, where you will additionally identify opportunities for quality and process improvements in pre-clinical development.

**Responsibilities**:

- Plan, perform, and report on QA inspections and suppliers audits to assure the Test Facility Management is in compliance with relevant national and international requirements for GLP/ISO 17025 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, reporting for compliance with the GLP principles.
- Support the review of test reports for ISO 17025 documentation and support management review and other relevant activities.
- Help prepare our 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 and ISO 17025) 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/ISO 17025 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
- Experience in a laboratory environment (chemical/biologic analyses) and participation in quality assurance related 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 e.g. ISO 170205 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.

Why Join Us?

We are bound by our shared passion for making a positive impact on the lives of patients and consumers. Vectura Fertin Pharma is a place where you can help shape the future of healthcare, where we collaborate, support, and inspire each other to achieve the best outcomes. As a growing business, we can offer a wealth of opportunity to develop your career both locally and in international settings.

We embrace hybrid and flexible working and are centered on delivering a ‘purpose-driven’ experience for all our employees.

Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong.

**Singapore**:
50 Science Park Road
02-07 The Kendall
Singapore 117406