Experience

Xepa-Soul Pattinson (Malaysia) Sdn Bhd

• Malaysia
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Regulatory Affairs Executive

  • Oct 2022 - Present

  1. Prepare, review, and submit dossier for scheduled poison products, non-scheduled poison products and cosmetic products for registration and variation in ASEAN countries (e.g. Malaysia, Singapore, Myanmar and Brunei).2. Involve in tender products participation for hospitals, ministries, and private markets to achieve business goals.3. Review and proofread Finished Product Specification and Work Instruction before being implemented for Quality Control analysis, by referring to monographs (USP, BP and EP).4. Key liaison between stakeholders (e.g. planning, supply chain, and business team) with regulatory authorities. Show less

• Quality Assurance Intern

  • Mar 2022 - Sep 2022

  1. Conducted IPQA testing for solid and liquid dosage forms, and revised SOP regarding IPQA testing referring to USP, Ph.Eur., and BP. 2. Prepared validation documents which include protocol and report of IQ, OQ, and PQ for equipments, shipping processes, and systems. 3. Managed the CAPA documentation for Change Control and Customer Complaint governed by Quality Management System (QMS) complying to ISO9001:2015 standards. 4. Engaged in the execution, data analysis, and report writing for Good Distribution Practice (GDP) which covers storage and distribution practices. 5. Actively contributed to the completion of Annual Performance Review of Purified Water System and Product Quality Review (PQR) for all manufactured products by reviewing data and trending analysis. Show less