Quality Assurance Executive

5 days ago

Seremban, Malaysia HALAGEL (M) SDN BHD Full time

1. To ensure products manufactured or distributed comply with the required regulations, such as Food & Drug Administration (FDA), Medical Device Authority (MDA). 2. To assist Manager to ensure the appropriate licensing and legal compliance of products in order to control the safety and efficacy of products. 3. To assist Manager to manage and facilitate all submissions e.g 510(k) and / or renewal license, product listing and registration/certificate. 4. Liaising with regulatory authorities and designated agents. 5. Provide ongoing support to product development for regulatory issues and questions. 6. Provide regulatory support to currently marketed products necessary. 7. Keep up to date with changes in regulation legislation, guideline and etc. 8. Assures the on going compliance by reviewing company practices and provide advice on change to systems, such as Technical File, Risk Management file, ISO documentation and other regulatory issues. 9. To update Technical file and all file related regulatory documentations when necessary. 10. Review labelling, storage and packing requirements in accordance to Packing Material Labelling Requirement Checklist. 11. Conduct Internal Quality Audits for ISO 13485. 12. Provide training, guidance and coaching to subordinates (if any).
Incorporated August 1997 as a trading company, Halagel (M) Sdn Bhd was the sole importer and distributor of Halal Empty Hard Gelatin Capsule and Halal Food and Pharmaceutical grades bovine gelatin. Today, Halagel® continues to distribute the best quality edible and pharmaceutical grades gelatin that meets the highest international standards and specifications to be a leading supplier and distributor for food for manufactures in Malaysia.Nowadays, Halagel® has broadened its business activities from purely trading to manufacturing and distributing an entire range of Halal products under the Halagel® brand. On top of that with its recognized GMP facility, Halagel® also undertakes contract manufacturing for Softgel products, Toothpastes, Rock Salt and Cosmetics for private labels.Recently Halagel® have been successfully accredited as Certified ISO company for ISO 9001: 2015 (Quality Management Systems), OSHAS 18001:2007 (Occupational Safety & Health Management Systems), ISO 14001:2015 (Environmental Management Systems) and HACCP (Hazard Analysis Critical Control Point) from KGS Certification (certified accreditation body under Standard Malaysia).Halagel® is not only certified HALAL by the Islamic Development Department of Malaysia (JAKIM) but also by the Indonesia and Thailand Halal authorized body.
Bachelor's or Equivalent

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