DURGAH DEVI MANIKIAM
Regulatory Technolosgist
Subang Jaya
Summary
With over 10 years of working experience in science industry, seeking to maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
12
12
years of professional experience
3
3
years of post-secondary education
3
3
Languages
Work History
Regulatory Technologist (Raw Material & Traded Goods)
Kerry Taste & Nutrition (EMEA)
7 2021 - Current
- Responsible for supporting the execution of various Traded Goods & Raw Material request in timely manner
- Review and manage specification approval for all raw materials for accuracy and legality
- Ensure all raw materials comply with policies and regulations.
- Support site audits to cover traceability of incoming raw materials
- Manage multiple project and deliverance of the result in timely manner.
- Review and complete customer specification & queries in timely manner
- Coordinate & develop effective working relationship with (RDA, QA, Operations, Procurement & commercials) external stake holders.
- Delivered exceptional customer support by resolving technical issues promptly and effectively, leading to increased client satisfaction and retention
- Established culture of continuous learning and professional development within the technology team, enhancing overall skills and capabilities
- Used SAP ECC, MDG, Optiva, Salesforce & Decernis on regular basis and developed advanced proficiency
- Streamlined workflow efficiency by automating repetitive tasks and improving overall processes
- Proactively identified opportunities for process improvements which led to substantial time savings within the organization
- Mentored junior team members to enhance their technical skills and improve overall team productivity
- Created detailed technical documentation for internal use, fostering better understanding of complex scenarios among all parties involved
QMR cum QA/QC
Me dDev Manufacturing Sdn Bhd
2019.10 - 2021.06
- Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality
- (IQC, IPQC and OQC)
- Document internal audits and other quality assurance activities
- Identify training needs and organize training interventions to meet quality standards
- Coordinate and support on-site audits conducted by external provider.
- Collaborated with cross-functional teams to ensure seamless integration between design, manufacturing, and quality control processes
- Identified opportunities for process improvement through analysis of measurement data and implemented corrective actions when necessary
- Contributed to successful audits by maintaining comprehensive documentation related to production activities including calibration logs, inspection reports, and standard revisions
- Managed multiple projects simultaneously, prioritizing tasks to meet deadlines without compromising quality or accuracy
- Ensured compliance with industry standards, maintaining meticulous records of inspection results
Reference Business Executive
Subang Jaya Medical Centre (SJMC)
2019.04 - 2019.10
- Handle customer inquiry via emails, phone call and walk-in for laboratory diagnostic test & provide quotations
- Update documentation related to audits & ad hoc task as instructed by manager.
- Established and maintained strong relationships with customers, vendors and strategic partners
- Enhanced customer satisfaction, addressing and resolving client concerns promptly and professionally
Food Technologist cum Microbiologist
Chemical Laboratory Sdn Bhd
2017.10 - 2018.06
- Conduct many types of chemical & microbiological analysis based on Standard operating procedures
- Develop new testing methodology on chemical analysis
- Organise, execute, supervise, and monitor daily laboratory operation, instrument maintenance
- Proficient user of HPLC Waters system
- Maintaining ISO 17025 documentation 9of the laboratory.
Contract Research Officer
SIRIM BHD , IBRC
2012.04 - 2016.10
- Handled many natural product research activities involving different types of extraction, fractionation and compound purification
- Good hands-on skills in phytochemical screening and chemical analysis of natural products
- Presented research findings at conferences, contributing to the dissemination of knowledge within the field.
- Participated in International EBN Industry Conference 2014 & 2016; won third prize in best poster presentation category and Malaysia Technology Expo 2015 ; won Bronze medal under the category of Invention & Innovation award
- Assisted in pharmacokinetics study and in-vitro study on the plant extract activity in testerone hormone inhibition
- Assisted in nano dispersion development for product formulation, encapsulating the active compound in nano size molecules
- Utilized various quantitative and qualitative research methods tailored to specific project objectives
- Developed SOP, code of practices, for operation and instrumentation and laboratory analysis
- Organized and facilitated investigator and coordinator meetings, conferences and events associated with research activities
- Evaluated existing research methods, identifying areas for improvement and implementing best practices
- Established strong working relationships with stakeholders, facilitating communication and collaboration on research projects
- Mentored junior researchers, fostering professional growth and enhancing team dynamics
Education
BSc Biomedical Science - Biomedical Sciences
Management & Science University (MSU)
Malaysia 2010.01 - 2013.01
Skills
Technical skills in laboratory analysis; HPLC, PREP HPLC, ICP analysis
Practical knowledge in ISO 9001, 13485, 14971 and 17025
Excellent Communication
Trained internal auditor for ISO 9001 & ISO 13485
Proficient user in MS office application, Word, Excel, Outlook, Publisher & PowerPoint
Salesforce, SAP ECC, Optiva, MDG, Decernis.
Multitasking Abilities
Teamwork and Collaboration
Problem-Solving
Additional Information
Current salary: MYR 6400
Expected Salary: MYR 6800
Notice period: Three-month
References
- Dr. Theanmalar, Senior Researcher, Internship Supervisor, +6013 3980 625, thean@sirim.my
- Mrs. Thavamanithevi, Associate Researcher, Supervisor, +6013 3017 293, thava@sirim.my
- Mrs. Sarifah Rejab, HOD, Project Leader, +603 5544 6952, sarifah@sirim.my
Timeline
QMR cum QA/QC
Me dDev Manufacturing Sdn Bhd
2019.10 - 2021.06
Reference Business Executive
Subang Jaya Medical Centre (SJMC)
2019.04 - 2019.10
Food Technologist cum Microbiologist
Chemical Laboratory Sdn Bhd
2017.10 - 2018.06
Contract Research Officer
SIRIM BHD , IBRC
2012.04 - 2016.10
BSc Biomedical Science - Biomedical Sciences
Management & Science University (MSU)
2010.01 - 2013.01
Regulatory Technologist (Raw Material & Traded Goods)
Kerry Taste & Nutrition (EMEA)
7 2021 - Current
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