Are you inquisitive and self-driven? Will you make a difference to our company and your colleagues around you? If the answer is yes, ja, oui or igen, then we’d like to hear from you.
We are looking to recruit an action-oriented problem solver with a Bachelor’s or Master’s degree in a scientific discipline with at least 5 years’ of relevant ISO, GLP or GxP experience in a pharmaceutical, biologics or biotechnology company. Should possess knowledge and understanding of regulatory requirements and expectations for data systems including 21 CFR Part 11. Advanced knowledge of OECD principles of Good Laboratory Practices, knowledge of other quality systems such as FDA GLP Principles, cGMP, ISO, GCP and AAALAC is an advantage. The ability to apply knowledge & experience to develop creative & workable solutions to institute quality management needs is a plus.
RISE TO THE CHALLENGE
Philip Morris International Research Laboratories Pte Ltd is seeking a talented individual to join our team. You will be responsible for establishing and maintaining a Quality Assurance (QA) program for Good Laboratory Practices (GLP) for non-clinical studies to assure the Test Facility Management (TFM) and management that the facilities, equipment, personnel, methods, procedures and practices, records and systems are under control for each non-clinical laboratory study, and are in conformance with GLP regulations. You are also responsible for the quality compliance monitoring of non-clinical laboratory studies conducted in the Singapore facility, and the implementation of local GLP compliance program for research based studies, providing support to monitor that these studies are performed in accordance with the local and global Quality Management Systems (QMS). This position is also accountable for the assessment of GLP compliance training needs, delivery of robust GLP compliance training programme, and identifying opportunities for quality and process improvements in non-clinical development. In addition, you will also be responsible for the quality oversight of suppliers and contract laboratories for non-clinical laboratory studies.
• Monitor non-clinical laboratory studies throughout their conduct and reporting for quality compliance with the GLP regulations. Responsible for ensuring that all non-clinical studies outside the scope of GLP are conducted and reported in accordance with the relevant QMS, including assessment of quality and operational excellence. Coordinate audits/inspections from internal or external bodies to ensure that these are managed successfully. Communicate and interface with regulatory authorities and accreditation bodies. Prepare the test facility in Singapore for inspections readiness, including hosting regulatory inspections/accreditations, and managing the corrective and preventive actions (CAPAs) in response to internal audits and regulatory inspections. Implement quality governance aligned with the QMS for the related areas.
• Develop, revise and maintain new and existing QA related standard operating procedures (SOPs), work instructions (WKIs) and forms according to the Singapore facility’s QMS. Perform the quality review of new and existing controlled-documents (SOPs/WKIs/Forms) for completeness, accuracy, data integrity and maintenance in compliance with GLP standards.
• Plan, schedule, perform and report routine and non-routine facility-, process-, systems- and study-based inspections to assure TFM and management that internal procedures/standards are in compliance with relevant national and international requirements. Perform verification of study plan(s) to ensure that study information required for compliance with GLP requirements are complete and documented. Responsible for the inspection of final reports to verify that the methods, procedures, and observations are accurately and completely described as per study plan, and that the reported results accurately and completely reflect the raw data of the studies.
• Monitor GLP studies throughout their conduct for compliance with GLP principles through verification of the study plan and relevant amendments; conducting study based inspections (including critical phases, data and final report); process-based and facility-based inspection in compliance with GLP principles and relevant regulations, and to promptly report inspection results in writing to TFM, management and study director; and to prepare and sign the QA statement to be included in the final report. Conduct study-based, process-based and facility-based QA inspections of suppliers and external laboratories in accordance to relevant guidelines and standards. Review that the CAPAs resulting from audits/inspections are feasible, adequate and efficient for implementation internally or by the external parties. Report audits/inspections outcome promptly to TFM, study director and management.
• 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 compliance on a global basis including local compliance enforcement experience with health authorities.
• Perform the quality 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.
• Responsible for developing training materials and providing regular training on the QMS and GLP awareness for new and existing staff, including regular training on quality-related SOPs/WKIs.
• Manage the facility's Nonconformance (NC) & CAPAs reporting programme. This includes the evaluation of NC/CAPA reports, reports process updates, status and follow-ups to ensure that each NC & CAPA have been adequately addressed and closed. Monitor and report quality Key Performance Indicators (KPI) with respect to GLP compliance.
FIND A NEW PATH
Our company offers you a fresh perspective. Here, you will never stop exploring and discovering. We take on-the-job learning to another level, giving you every opportunity to develop your career and reach your full potential. With innovative technologies, services, and processes, backed by a competitive salary and compensation package, you will work in a professional setting with clients and team members from all over the world.
GOT SOMEONE IN MIND?
If you believe you would be a good fit to the requirements of the role, please submit your application online by 15 September 2019. Only candidates who fit the hiring requirements will be contacted. The successful candidate will be hired on the local employment terms and conditions in Singapore.