Senior Quality Assurance Executive (Regulatory Affairs and Lab Operator)

• Nov 2017 - Present

QA & RA• Act as QA team leader• Liaise with regulatory consultants and authorities including BPFK and DVS, as well as regulatory officers of manufacturer and supplier abroad• Compile, prepare, review and submit an application for Import, Manufacturing and Seller License, variations and license renewals of the company to BPFK and DVS• Prepare registration documents for requested countries, such as FSC and Manufacturing Cert and arrange for legalization of certs withregulatory body• Regular review product label and packaging of local and exported products to ensure adhere to labelling requirements of BPFK and DVS• Ensure appropriate licensing, marketing and legal compliance veterinary products to control products' safety and efficacy • Advice manufacturers on regulatory requirements, undertaking and managing regulatoryinspections• Active updating and tracking of all documents include GMP MS1514:2009, ISO9001:2015 and FAMI-QS requirements• Act as lead auditor to conduct internal audits with audit team and liaison with externalauditor• Prepare, amend and monitor of SOPs, working instructions, manuals and ensure significantchanges are appropriately communicated• Assist in implementing and providing continuous in-house trainings on applicable standardsfor all employees within organization• Arrange sample to external Lab testing• Prepare COA for raw materials and finished product• Prepare MSDS for new incoming raw materials and finishedproduct• Prepare product label• Assist customer during factory visitLAB OPERATOR • Lead and guide the lab assistant• Stem cell preparation• Perform cell culture & harvest, thawing, cell counting, cell washing, packaging of cell products and store until delivery• Maintain laboratory apparatus/equipment in good condition by calibrating andtroubleshooting• Order chemical reagents, laboratory supplies, nitrogen gas and keep a close watch on the expiration dates to ensure quality control in lab