Preclinical Quality Lead (QMS/ Pharmaceutical)
Our client is a Leading Tobacco company in Singapore. We are currently looking for a Preclinical Quality Lead to support the operations
- Location: Central
- 5 Days Work
- Up to $8300 depending on experience
- Responsible for supporting the establishment and delivery of the Quality Assurance (QA) program for the Life Sciences Test Facility in Singapore in alignment with Good Laboratory Practices (GLP), other applicable regulations and supporting company NEU Test Facility.
- Leads the Life Science QA activities in the implementation of ISO 17025 and other applicable standards pertinent to pre-clinical research and/or toxicological assessments in order to verify that the studies are performed in accordance with the applicable regulatory frameworks, best practices and QMS.
- Responsible for the quality oversight of suppliers and contract laboratories for pre-clinical research and/or toxicological assessments, and in identifying opportunities for quality and process improvements in pre-clinical development.
- Support the alignment of the R&D strategy and its deployment across the Life Sciences QA organization. Collaborates across departments and key R&D business stakeholders to ensure targets are achieved. Consistently builds GLP, GCLP and ISO 17025 capabilities, by providing continuous coaching, mentoring and advice to peers, colleagues and other key stakeholders.
- Plan, schedule, perform and report facility-, process-, systems- and study-based inspections and suppliers audits to assure TFM and management that procedures/standards are in compliance with relevant national and international requirements for GLP/ISO 17025 for both internal and external entities.
- Monitor pre-clinical laboratory studies throughout their conduct and reporting for compliance with the GLP regulations through verification of the study plan and relevant amendments; conducting study-based inspections (including critical phases, data and final report) in compliance with the relevant standards/regulations, and to promptly report inspection results in writing to management and study director; and to prepare and sign the QA statement to be included in the final report.
- Provide review of test report for ISO 17025 accredited methods, maintain ISO 17025 documentation and support management review and other relevant activities.
- Sets team direction to contribute to adherence of PMI to requirements and regulations. Coordinate audits/inspections from internal or external bodies, for example Enterprise Singapore (formerly SAC), AVA, AAALAC etc, to ensure that these are managed successfully. Communicate and interface with regulatory authorities and accreditation bodies.
- Prepare PMI R&D Test Facility for inspection readiness, including hosting regulatory inspections/accreditations, and contributing to the corrective and preventive actions (CAPAs) reporting in response to internal audits and regulatory inspections.
- Collaborate across departments and key R&D business stakeholders to ensure targets are achieved to foster the notion of ownership of quality and to strengthen a quality mindset in the organization, through direct interaction with the related functions. Keep abreast of relevant regulations to remain an expert in understanding of GLP/ISO 17025 compliance on a global basis including local compliance enforcement experience with Health Authorities.
- Develop and maintain QA QMS documents in alignment with PMI Quality Organization.
Perform QA review of R&D QMS documents (SOPs/WKIs/Forms) to verify their conformance with PMI QMS and applicable standards/regulations.
- Responsible for developing training materials and providing regular training on the QMS (e.g. GLP and ISO 17025) awareness for new and existing staff.
- Contribute to the facility's Nonconformance (NC), Corrective Action Preventive (CAPA) and Lab Change Request (LCR) reporting programme. This includes the evaluation of NC, CAPA and LCR records and necessary follow-ups to ensure that each record is adequately addressed and archived. Monitor and report quality Key Performance Indicators (KPI) with respect to QMS compliance.
- Bachelor's degree in scientific discipline (Life Sciences, Biology, Chemistry etc.), MS or equivalent is ideal
- More than 10 years' experience preferably in the area of life sciences
- Minimum 3-5 years' experience in leading people or team work preferably within a laboratory environment
- At least 3 years' experience in laboratory environment with GLP or ISO 17025 quality system
- Experience in participation, management and hosting of external regulatory body inspections
- Proven lead auditor experience
- Experience in maintenance of quality management systems and continuous improvement
- Excellent working knowledge of OECD Principles of Good Laboratory Practice, knowledge of other quality systems such as ISO 17025, FDA GLP Principles, cGMP, GCP and AAALAC is ideal
If you possess above relevant skillsets, please send in your updated CV in word format to Apple.email@example.com
Lim Pey Chyi
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579