Regulatory Affairs cum Halal Executive - DZR Pharma Manufacture Sdn Bhd & DZ Smart Lab Sdn Bhd
(2022-03 - 2025-03)
- Managed the registration process for 15+ pharmaceutical products annually, compiling and submitting dossiers while liaising with regulatory bodies to ensure timely approvals.
- Managed the Sijil Indikasi application, variations, COH process, MAL renewal, CPP, and CFS applications for post-registration products.
- Prepared official letters regarding marketing and distribution rights for clients to support online marketing purpose.
- Prepared dossiers for Cosmetic Notification applications and Type 1 & Type 2 change processes.
- Oversaw product packaging design and liaised with QUEST3+ for approved designs.
- Responsible for renewing GMP schedule inspections for both companies every two years.
- Co-led 2 NPRA audits, resulting in minimal non-conformities.
- Provided 2 internal cosmetic regulatory training sessions to the Cosmetic Quality department.
- Managed CAPA reports and liaised with the Quality department.
- Created a Full Investigation Report form for CAPA reports and traceability purposes.
- Developed 20+ formulas, including powder, tablet, and capsule dosage forms.
- Participated in 5+ seminars related to GMP regulations, conducted by NPRA speakers.
- Successfully developed and registered 5+ new products, overseeing the entire process from formulation and R&D to obtaining the MAL number.
- Designed 30+ posters for MAL product information to be used for marketing and client reference.
- Responsible for renewing company-related certificates, including GMP and PBT licenses, annually.
- Trained and supervised 4 batches of interns over 4 months.
- Ensured pharmaceutical and cosmetic products met halal regulatory standards by preparing and submitting regulatory documents to JAKIM & JHEAIK, resulting in zero compliance issues.
- Led 3 halal audits, successfully achieving compliance with all regulatory requirements.
- Oversaw OEM halal certification for 2 premises and 60+ products, ensuring compliance with halal standards and conducting annual reviews.
- Provided 2 internal halal training sessions: halal awareness and halal management.
- Attended 6 halal training sessions organized by JAKIM, JHEAIK, and other HPB-authorized organizers.
- Responsible for preparing internal audit checklists, conducting halal internal audits, and recording meeting minutes.
Pharmacist Assistant - Mega Kulim Pharmacy Jitra
(2022-03 - 2022-03)
- Provided support to 30+ customers per shift, addressing inquiries and promoting wellness programs.
- Managed stock levels by ordering and organizing 300+ medications monthly, checking for expired products, and reducing waste by 15%.
- Assisted pharmacists with 10+ patient consultations weekly, managed medication therapy for 50+ patients, and participated in 2 educational outreach events monthly.
- Assisted customers in purchasing over-the-counter products and medications, and was also involved in promoting sales of health and wellness products.
- Ensured the pharmacy and work areas were tidy and safe for customers and staff, including managing controlled substances and hazardous medications.
- Assisted customers in finding the products they needed and managed patient flow in the pharmacy.
Pharmacist Assistant Trainee - Hospital Tuanku Ja'afar Seremban
(2016-05 - 2017-08)
- Supported pharmacists in processing an average of 150 prescriptions daily, ensuring accuracy in dosage and instructions.
- Conducted medication inventory checks, reducing discrepancies by 20% through diligent record-keeping and auditing.
- Provided basic counseling on over-the-counter products, assisted in preparing and dispensing medications including IV solutions, sterile compounds, and oral medications, under the supervision of pharmacists.
Industrial Trainee - DXN Pharmaceuticals Sdn Bhd
(2021-08 - 2022-12)
- Complied with GMP guidelines and regulations, ensuring 100% adherence to company procedures.
- Assisted in auditing over 500 stock items and inventory, contributing to a more accurate record-keeping system.
- Prepared 20+ Internal Delivery Order forms weekly through the ERP (Enterprise Resource Planning) system, streamlining the delivery process.
- Provided basic counseling on over-the-counter products under supervision.
