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Job Details

Location
Singapore
Salary
Competitive
Job Type
Permanent
Ref
BH-157046
Contact
Joanne Koo
Contact email
Email Joanne
Contact phone
65 6692 0751
Posted
3 months ago
  • Work location at Science Park, Singapore
  • Single contributor, reporting to Quality Compliance Manager
  • Work in a modern R&D facility with cutting edge equipment
Our client is a US MNC with a R&D facility in Singapore, employing over 60 scientists and technical staffs.

They are currently seeking a talented individual to join the Quality Compliance team. The successful incumbent will establish and maintain 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

JOB RESPONSIBILITIES

• 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

• Develop training materials and provide 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


REQUIREMENTS

  • Bachelor or Master Degree in a scientific discipline
  • Minimum 5 years of relevant ISO, GLP or GxP experience in a pharmaceutical, biologics or biotechnology company
  • 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
  • Demonstrates the ability to apply knowledge and experience to develop creative and workable solutions to institute quality
 

EA Personnel No R1109555
EBC Connect Pte Ltd
License No 17C8975