Experience

Lucence

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior QA

  • Aug 2020 - Present



Hanalytics Pte Ltd

• Assistant QA/RA Manager

  • Oct 2019 - Jun 2020



TUV RHEINLAND SINGAPORE

• ISO 13485 AUDITOR

  • Mar 2018 - Sep 2019

  Certification Body for EN ISO 13485, MDSAP, IVDD and MDDTUV Rheinland Singapore Date Start: 01-04-2018 –01-10-2019Medical AuditorRepresentative accomplishments:Successfully completed 28 External Audits on JAB ISO 13485 and EN ISO 13485 Certification Audits in full and within project timelines. Certification Body for EN ISO 13485, MDSAP, IVDD and MDDTUV Rheinland Singapore Date Start: 01-04-2018 –01-10-2019Medical AuditorRepresentative accomplishments:Successfully completed 28 External Audits on JAB ISO 13485 and EN ISO 13485 Certification Audits in full and within project timelines.



MP Biomedicals

• United States
• Biotechnology Research
• 400 - 500 Employee

• Senior QA/RA Officer

  • Sep 2001 - Apr 2018

  Representative accomplishments:• Successfully implemented and maintained the QMS Documentation in compliance to EN ISO13485, In-vitro Diagnostics Directive -98/79/EC, 21 CFR 820: USA FDA Quality System Regulations and Medical Device Single Audit Program AU P0002.004 (MDSAP) Regulations.• Submitted successfully 27 IVD products for world-wide product registration in terms of notification, specifically those of the US FDA QSR, EU IVDD 98/79/EC, Health Canada, Australian Therapeutic Goods Authority (TGA), ANVISA Federal Law No. 6360/1976, Japanese QMS Ministerial Ordinance on Medical Devices and In Vitro Diagnostics; Taiwan GMP, Korean Medical Device Act and Singapore Health Sciences Authority (HSA).• Provide timely regulatory market intelligence to support setup in new markets.



Beecham Pharmaceuticals Pte Ltd Singapore

• Microbiology Laboratory Technician

  • Jul 1982 - Oct 1989

  Handling Microbial contamination testing on finish products. Toxicity Test, gramme staining, swaps test on work areas and production areas. Handling Microbial contamination testing on finish products. Toxicity Test, gramme staining, swaps test on work areas and production areas.