Job Description

Job Requirements:

1. To ensure companywide compliance with the quality standards and  regulations through the implementation and continuous update of a comprehensive quality assurance system for Duopharma  Manufacturing  (Bangi) Sdn. Bhd.
2. Responsible  for  the  execution  and  regular  review  of  the Quality Systems in accordance to the regulatory requirements (PICs Guideline), relevant QMS Standards (ISO 9001:2015,ISO 13485 and GDPMD).
3. Ensure company products  are manufactured in accordance to protocols accepted for registration.
4. To approve finished product  for sale, BMR master  copy and PQR.
5. To check for product complaint, recall, audit and SAP bulk BOM maintenance.
6. Oversee and ensure  plant hygiene.
7. Monitor contract manufacturers and service providers of GMP and GDP related  activities.
8. Ensure effective escalation  of quality issues to management.

General Requirements:

• Minimum Bachelor in Science applied Chemistry or Chemical Technology
• Minimum 8 years working experience
• Knowledge in GMP, GDP, ISO and GDPMD
• Knowledge in System Auditing
• Critical Thinking and Problem-Solving Skills
• Microsoft Office (Word, Excel, Powerpoint etc.)
• Novatek EQMS Software
• Statistical Analysis
• On-time delivery of all assigned tasks, independent and takes the initiative to learn and complete tasks.

Job Requirements