Nelson Ng
Regulatory Affairs and Quality Assurance Executive (Regional - Asia Pacific) at Schülke & Mayr- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
Topline Score
Bio
Credentials
-
SS 620:2016 (2021) Internal Auditor Course
GICGAug, 2022- Nov, 2024
Experience
-
Schülke & Mayr
-
Germany
-
Pharmaceutical Manufacturing
-
300 - 400 Employee
-
Regulatory Affairs and Quality Assurance Executive (Regional - Asia Pacific)
-
Aug 2021 - Present
Regulatory Affairs • Registration and timely renewal of product licenses both locally (SG) and across the APAC region.(>300 MAH across region) • Countries collaborated for product registration & distribution: Germany, Australia, China, India, Hong Kong, Malaysia, Korea, Taiwan, Brunei, Indonesia, Vietnam, Philippines and Myanmar. • Product List comprises of Pharmaceuticals, Medical Devices (Class A to C) and Cosmetics. • Change Notification, Drug Variation, Dossier Transfer/Creation (CSTD) and label management. • OEM/ODM projects with Contract Manufacturers (CMO). Method transfer, product development, gap analysis and risk management. • Distributor/Registrant changes and license transfers in the APAC region. • Preparation of Regulatory Service Agreement (RSA) with regional distributors. • Registration of local sales promotion mechanics and advertisements with HSA. • Maintain Drugtrack, Docubridge and other Regulatory Affairs related databases. • Notarization (Notary Public), Legalization and Apostille of documents. Quality Assurance • Oversee the quality assurance aspect of locally conducted activities and those undertaken by APAC distributors, third party logistics (3PL) warehouse and CMOs. • OEM/ODM projects. Product development, Method transfer, Product lifecycle management/stability protocol planning (ICH guidelines). • Certified SS620:2016 GDPMDS Internal Auditor (GIC). Coordinated GDPMDS internal audit, external audit and management review. • Trained with ISO13485: 2016 Quality Management System - Medical Devices, conducted audit on CMOs. • Maintains the Site Master File (SMF) and Standard Operating Procedures (SOP) of the company. • Complaint handling. Complaint investigation of product owners or CMOs, Root cause analysis (RCA) and CAPA evaluation. • FSCA and Adverse Event protocols. • Review and release of COAs. • Ad-hoc product inspection at 3PL using the AKL sampling method. • Create work instructions (WI) for product redressing activities in the region. Show less
-
-
-
MSD
-
United States
-
Pharmaceutical Manufacturing
-
700 & Above Employee
-
Chemist
-
Feb 2017 - Aug 2021
Quality Control Laboratory In-Process Control (IPC Shift Lab) • Conduct analytical testing for In-Process, Intermediate and Finished Product of APIs, adhering to GMP requirements. • Assistant Team Leader & Test Reviewer. • Oversees laboratory audits and facilitates shift handover meetings. • Undertakes test assignment and coordinates work planning for the team. • Troubleshoots analytical instruments and test methods. • Highly skilled in Empower for LC/GC Chromatographic analysis, setting up test-methods, optimizing integration methods, and conducting analysis of test results. • Conduct vessel cleaning test-validation for manufacturing vessels following each product campaign and during new product/technology transfer. • Effectively utilizes GLIMS/LIMS and LabX for release of test results, while also maintaining laboratory instruments records using SAP/Comet. • Skilled in operating various Chromatographic instruments (LC/GC - Assay, Impurities, Residual Solvent-Headspace) as well as conducting Wet Chemistry tests (IR, AAS, ICP, KF -Volumetric & Coulometric, pH, Heavy Metal). • Engaged in diverse projects, including Installation Qualification (IQ), crafting comprehensive SOPs, and creating new datasheets in anticipation of the LabX launch. • Dynamic and fast-paced environment with stringent result release lead times. • Commenced as a 1-year contract staff member and demonstrated outstanding performance, leading to being selected from a pool of candidates and offered a permanent position at the conclusion of the contract term. Show less
-
-
-
Health Sciences Authority
-
Public Safety
-
500 - 600 Employee
-
Research Assistant (Internship)
-
Jan 2016 - Jun 2016
• Attached to the Pharmaceutical Laboratory. • Engaged in research and development of leading-edge Analytical testing methods employing LC/MSMS for Pharmaceutical drugs. • Using the Advanced Orbitrap Q-Exactive Plus system. Led the creation of a High Resolution Accurate Mass (HRAM) database comprising of 250 pharmaceutical analytes within an impressive 3 months timeframe. • Received a recommendation/testimonial letter from my supervisor, Dr. Kee Chee Leong, an accomplished PhD Senior Analytical Scientist. Show less
-
-
-
Lonza
-
Switzerland
-
Pharmaceutical Manufacturing
-
700 & Above Employee
-
Internship Trainee
-
Feb 2010 - Jul 2010
Nanyang Polytechnic Internship Programme • Attached to the Quality Control (Environmental Monitoring) - QCEM department. • Gained experience in diverse industrial air sampling techniques and trained in GMP/GDMP principles. • Achieved a remarkable 'A' grade for his performance during the internship program. Nanyang Polytechnic Internship Programme • Attached to the Quality Control (Environmental Monitoring) - QCEM department. • Gained experience in diverse industrial air sampling techniques and trained in GMP/GDMP principles. • Achieved a remarkable 'A' grade for his performance during the internship program.
-
-
Education
-
2012 - 2016
Nanyang Technological University
Bachelor of Science with Second Class Honours (Upper Division), Chemistry and Biochemistry -
2007 - 2011
Nanyang Polytechnic
Diploma, Chemical and Pharmaceutical Technology (Chemical & Biomedical Engineering)
Community
