Iris C. Email & Phone Number

Singapore

• Develop and implement QMS with cross-functional team to improve quality processes that lead to overall increases in service quality, and process efficiency and compliance to regulations• Lead and drive compliance to all quality processes and procedures developed for in-vitro and in-vivo preclinical services and products, clinical services, and consumables business units for Invitrocue and Invivocue• Lead to champion and developing the culture of quality improvement and awareness. • Plan, develop and support the training of employees in Quality Management and Quality processes and procedures.• Conduct internal audit to close compliance gap as per ISO 15189, HCSA and HBRA requirements. Lead the audit process from preparation, attendance, follow up to close-out Act as liaison person for any external audits or inspections by regulatory authorities or Clients.

1. Lead a team of 6 to ensure smooth workflow of batch release and document management in the department to ensure compliance to quality system requirements; manage day-to-day issues of the department. Plan and deploy resources to manage workload within the team. 2. Change Control Lead for the Plant for the Trackwise system.3. Local SME on computer system validation & controls

1. Review documents and issuance of SOPs/ forms/ various quality related documents via PLM system (Teamcenter). Assist in document archival and destruction, and maintenance of document management system. 2. Review batch record and provide backup support to system release and final product release. 3. Lead or assist any Corporate / Divisional or site projects / initiatives /implementation related to quality systems (involved in electronic batch records, control form system, global batch tracker tool, maximo,)4. Coordinate and provide backend support for all major external inspections (such as FDA, HSA & TUV)5. Plant contact for all regulatory filling and product registration with respective country Regulatory Affairs across Baxter

Singapore

• Manage the Standards Development Committees and its Working groups in addressing various standardisation issues for the chemical and related industries under Enterprise Singapore and SCIC. Support standards development by following up on various initiatives and work plans put forth by the committees.• Planning of organisation of events such as standards industry awareness event, standards launches, standards workshops etc.• Manage the SCIC Committee and its Workgroups in addressing process safety issues for the chemical industry. This includes managing all related meetings involving industry practitioners, Government regulators, 3rd party consultants as well as the follow-up actions on the various initiatives and workplans put forth.•Secretariat and coordination support to Safety Case Joint Working Group that supports the Major Hazards Installation (MHI) Committee.• Supporting role in technical and assessment guidance for Safety Case, including the organisation of awareness and capability building sessions for MHIs

• Design presentation posters for site expansion project to publicize the designs, functionsand specifications of different equipment.• Collaborated with cross-functional teams and develop Operator Asset Care Program toenhance equipment reliability and reduce the number of equipment problems by more than50%.• Supported engineers in plant troubleshooting using Distributed Control System (DCS) and reducethe number of deviations by more than 50%.• Assisted in preparation of GSK Production System(GPS) site assessment by aligning thecontinuous improvement activities to Six Sigma to achieve Level 3.5 GPS maturity in 6 basicelements (Performance Management, Problem Solving 5S, Operator Standard Work,Leader Standard Work and Gemba with Purpose).• Reviewed manufacturing batch sheets for documentation errors to ensure no violation of dataintegrity

Australia

Research Project titled: "Study of the binding affinity between monoclonal antibodies and staphylococcal protein A ligands by the application of isothermal titration calorimetry.Attached to a group of postgraduates, mainly to assist in conducting literature reviews, experiment execution with Isothermal Titration Calorimetry and data collection, in adherence to GDP and GLP.