Manager Research & development
11 years of experience
I am a highly skilled technical professional with over 11 years of hands-on experience in the installation, maintenance, calibration and troubleshooting of specialized equipment used in industrial, scientific domains. My primary area of expertise lies in supporting pharmaceutical Research & Development laboratories, with deep familiarity across analytical and formulation equipment.
In the pharmaceutical R&D sector, I have worked extensively with dissolution testers (USP I & II), disintegration and friability testers, tablet hardness testers, stability chambers, and high-shear mixers/homogenizers used in formulation development. I have also provided critical support for method development and validation studies through my expertise in operating and maintaining HPLC systems (e.g., Agilent 1100/1200 series, Waters Alliance), UV-Vis spectrophotometers (Shimadzu, PerkinElmer), FTIR spectrometers, and Karl Fischer titrators for moisture analysis.
My responsibilities have included:
Equipment Installation & Qualification (IQ/OQ/PQ) in GMP/GLP environments.
Preventive and Corrective Maintenance, reducing equipment downtime and improving lab productivity.
User Training & SOP Development, enabling laboratory staff to operate instruments effectively and safely.
Technical Documentation, including calibration logs, validation protocols, and service reports, in line with regulatory and audit requirements.
Fomulation design
Analytical method develpement
Compilation & submission of CTD for domestic manufacturing
Compilation & submission of E-CTD for ASEAN Countries
With strong problem-solving skills and an eye for detail, I serve as a reliable technical resource in fast-paced, regulated environments. My goal is to ensure the highest level of equipment functionality, user training, and documentation compliance to support innovation and quality in scientific research and pharmaceutical development.
I specialize in the operation, maintenance, and troubleshooting of a wide range of industrial & scientific equipment. My expertise includes, but is not limited to:
Pharmaceutical R&D Equipment: Dissolution testers, tablet hardness testers, friability testers, disintegration testers, stability chambers, and homogenizers.
Analytical Instruments: High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), UV-Visible Spectrophotometers, FTIR, and Karl Fischer titrators.
I am a highly skilled technical professional with over 11 years of hands-on experience in pharmaceutical Research & Development, with a strong focus on dosage form development, analytical method development, stability studies, and analytical method validation/verification. My expertise also includes the preparation and submission of CTDs for local regulatory authorities, as well as eCTD submissions for ASEAN countries. I am well-versed in technical troubleshooting, cost analysis, and regulatory correspondence, ensuring timely and compliant product development and registration.
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