YAMUNAH RAMAN
Technical Assessor ISO 15189 at Ministry of International Trade and Industry Malaysia- Claim this Profile
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English Professional working proficiency
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Malay Full professional proficiency
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Tamil Professional working proficiency
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Hindi Limited working proficiency
Topline Score
Bio
Credentials
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Technical Assessor ISO 15189
Ministry of International Trade and Industry MalaysiaSep, 2018- Nov, 2024 -
Good Clinical Practice (GCP)
Clinical Research MalaysiaMar, 2018- Nov, 2024
Experience
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Ministry of International Trade & Industry (MITI Malaysia)
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Malaysia
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Government Administration
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1 - 100 Employee
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Technical Assessor ISO 15189
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Jan 2019 - Present
•Audit (surveillance/assessment) medical laboratories for ISO 15189 compliance.•Outlined recommendations for correcting non-conformance in organization operation and scope of testing. •Monitored testing procedures and verified performance of tests according to established specifications, policy, procedure and protocol. •Gathered and reviewed current data to determine areas in need of improvement.•Provide non-conformance report and present to auditee the findings •Audit (surveillance/assessment) medical laboratories for ISO 15189 compliance.•Outlined recommendations for correcting non-conformance in organization operation and scope of testing. •Monitored testing procedures and verified performance of tests according to established specifications, policy, procedure and protocol. •Gathered and reviewed current data to determine areas in need of improvement.•Provide non-conformance report and present to auditee the findings
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Ministry Of Health, Malaysia (KKM)
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Malaysia
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Hospitals and Health Care
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700 & Above Employee
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Project Supervisor
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Oct 2017 - Sep 2019
Supervised dissertation projects for undergraduates (Degree/Diploma in Medical Laboratory) students from MAHSA, UITM, PTPL and MSU.
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Head of Chemical Pathology Cum Quality Manager
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Mar 2016 - Sep 2019
•Lead the development and implementation of the chemical pathology laboratory quality management system to comply with relevant aspects of ISO 15189 and Good Clinical Practice (GCP).•Responsible for the maintenance and continuous improvement of the preanalytical, analytical, post analytical prior to quality management system which comply to GLP, GMP, ISO 17025, ISO 15189, Occupation Safety & Health Act (OSHA), Medical Device Act (MDA) and Food Drug Act (FDA).•Actively participate in the induction and training of new laboratory staff and clinical staff (house officers, nurses and medical attendance) and ensure that their training requirements are met.•Interface with the Hospital Director, Head of Department and Quality Manager to ensure appropriate resource allocation and laboratory capabilities are available to deliver operation and research needs.•Participate in continuing professional development activities and ensure adequate participation of laboratory staff.•Ensure that all equipment is used and maintained in accordance with manufacturers guidelines and that all end-users receive appropriate validated training in the correct and safe use of equipment.•Involve actively in the production, continuous monitoring and updating of departmental standard operating procedures (SOPs), policies, forms and processes.•Communicate effectively with departmental and inter-departmental staff and take an active role in departmental meetings.•Ensure that internal and external quality control processes are scheduled and performed, and that appropriate CAPA measures are taken where necessary.•Supports sales in bid preparation and defense.•Preparing grant applications •Research publications.
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Peer Tutor
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Jul 2003 - Sep 2019
Tutoring Staff Nurses, Medical Assistant, House Officers, and Medical Officers on Pathology Diagnostic Services.
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Academic Tutor
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Jul 2003 - Sep 2019
Tutored undergraduates (Degree/Diploma in Medical Laboratory) students from MAHSA, UITM, PTPL and MSU.
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Senior Scientist (Transfusion) & Technical Manager
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Nov 2014 - Mar 2016
•Managed operational budgets wisely that resulted in significant savings. Involved actively in purchasing and inventory of reagents and consumables.•Involved in opening quotation/tenders for rental contract/purchasing of equipment, reagents and consumables.•Oversees Quality Assurance within the section including QC, maintenance documentation, procedure review/update, training and competency, etc.•Provides daily leadership in the section and readily available as issues arise and provide needed guidance.•Presented research findings to scientific audience and general public.•Conducted root cause analysis to enhance quality and laboratory processes.•Negotiated agreements between employees to clarify misunderstood directions and resolve conflicts affecting performance. •Updated, implemented and adhered to relevant Quality Management System Procedures, SOPs and Policies to meet ISO 17025, ISO 15189 and Good Manufacturing Practice (GMP) compliance requirements. •Investigated and resolved customer complaints to foster satisfaction.•Conducted customer satisfaction survey yearly.•Compiled, analysed and CAPA of key performance indicator (KPI).
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Senior Scientist (Haematology & Document controller)
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Jan 2008 - Oct 2013
•Examined blood samples to identified disorders such as coagulopathy (factor VIII and IX assays), thrombosis [lupus anticoagulant (LA), antiphospholipid antibodies (APA) and anticardiolipin antibodies (ACA)] and analysed leukemia cases to identify immunophenotyping using flowcytometry.•Ensured compliance to ISO 17025 and ISO 15189 by adhering to all Quality Management System Procedures, SOPs and Policies.•Understands and utilizes basic and advanced functions in the Laboratory Information system (LIS) and teaches these functions to laboratory staff and students as needed. •Continued to develop knowledge and expertise, by keeping abreast of relevant literature and attending meetings and courses where possible.•Familiarized with, and adhere to all laboratory and corporate occupational health and safety policies and procedures. •Ensured good co-operation and communication with other departments.•Demonstrated a responsible attitude and willingness to learn new procedures, produced new SOPs and in the review of those already established. •Conducted training and change management processes to improve operations.•Analysed operation plan, identified inefficiencies in existing processes, and tracked performance following implementation of improvements. •Performed evaluation, validation, calibration, maintenance for equipment and ensure in good working condition.
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Scientific Officer (Haematology & Transfusion)
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Feb 2003 - Jun 2006
•Performed haematological and transfusion testing requiring advanced knowledge in a prompt, reliable and comply to GLP, GMP, ISO 17025 and ISO 15189 by implementing and adhering to all Quality Management System Procedures, SOPs and Policies. •Assisted Head of department in management, continuous monitoring and updated quality control standards, methods and procedures to meet compliance requirements. •Sets up new methodologies, develops procedural protocols, and trains lab personnel and students in the performance of technical procedures and in the use of instrumentation. •Continue to develop knowledge and expertise. This is to be achieved by keeping abreast of relevant current literature and attending meetings and courses where possible in haematology.•Implement and adhere to the Company's Health & Safety Policy and not to compromise the health and safety of others.•Ensure that internal and external quality control processes are scheduled and performed, and that appropriate corrective and preventative measures are taken where necessary.•Communicate effectively with departmental and inter-departmental staff and take an active role in departmental meetings.
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Universiti Sains Malaysia
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Malaysia
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Higher Education
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700 & Above Employee
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Graduate Research Fellow
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Oct 2013 - Nov 2018
•Reviewed and understand research related literature.•Troubleshoot and customize experimental tools to respond to research questions. •Preparing grant applications •Screened patient records, databases and physician referrals to identify prospective candidates for blood sample procurement for research studies after informed consent. •Monitored unit budget to ensure financial objectives were met.•Develop and performed wet-lab and molecular genetic scientific research, using methods including, DNA/RNA extraction and purification, quantification and qualification of DNA, polymerase chain reaction (PCR), Sanger sequencing and high-performance liquid chromatography (HPLC). •Collaborate resources to complete research plan.•Gathered, organized and entered records of experimental work into SPSS and bioinformatics.•Develop hypotheses and performed bioinformatic analysis using ensembles, NCBI and succeeded in identifying novel Single nucleotide polymorphism (SNP) which cause acid amino and protein mutation and association between SAO and dRTA. •Maintained impeccable standards in managing cleanliness of the laboratory and chemical inventories, safely disposing of waste and accurately calibrating laboratory equipment. •Present research results at meetings and engage in result publication.•Authored professional scientific papers for publishing in peer-reviewed journals.•Attend research seminars and research new articles at Principal Investigator's request.•Communicate ideas and results with supervisor/members.•Develop figures and manuscripts for publications.•Oversee junior members.
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Graduate Research And Teaching Assistant
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Aug 2014 - May 2015
Tutored undergraduate students from School of Regenerative Medicine.
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Universiti Sains Malaysia
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Malaysia
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Higher Education
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700 & Above Employee
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Clinical Research Assistant
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Jul 2006 - Jul 2007
•Preparing grant applications •Screened patient records, databases and physician referrals to identify prospective candidates and recruited for research studies.•Educated patients regarding all facets of study participation, followed informed consent processes and maintained records.•Monitored unit budget to ensure financial objectives were met.•Worked with principal investigator and sponsors to ensure compliance with research protocols.•Performed biochemical, haematological experiments and Diego blood group identification.•Researched information regarding Association of Southeast Asian Ovalocytosis (SAO) and Diego blood group to assist professors with academic pursuits•Recorded, gathered, organized, entered data into SPSS, bioinformatics and maintained the source records. •Order supplies and equipment necessary for lab research duties, and unpack and organize delivered equipment and supplies. •Prepared literature for reports, presentations or submission to peer-review journals.•Prepare manuscript.•Completed administrative and research duties as per professor request.•Trained and supervised undergraduate students working on research projects.
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Education
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Universiti Sains Malaysia
Haematology-Molecular genetics, Doctrate -
2006 - 2007
Universiti Sains Malaysia
Masters in Science, Transfusion Science -
1999 - 2002
Universiti Putra Malaysia
Bachelor Degree in Science (Hons), Biochemistry
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