Full Time Regulatory Affairs - Quality Assurance Assistant Jobs, Salary up to MYR 2,500 in TERAJU PHARMA SDN BHD Selangor - Maukerja

RA/QA ASSISTANT EXECUTIVE JOB SCOPE

1. Coordinate& assist in company’s GDP & GDPMD record upkeeping/maintenance:

• Product complaint record
• CAPA/SCAR record
• Maintenance service record
• Temperature record
• Calibration & other related record

2. Coordinate & assist in company’s NPRA record upkeeping/maintenance:

• Wholesale record
• Import record
• Poison wholesales book
• PSO/DO record

3. Assist in Import Authorization (IA) of Dangerous & Psychotropic Drug application:

• Compilation of orders based on drug type
• Compilation of documents i.e.: PO/Permit etc
• Arrange for submission & collection of IA to NPRA
• Manage return IA to NPRA

4. Assist in executing Product registration with NPRA

• Supplement product registration
• Cosmetic product registration
• Pharmaceutical product registration
• Product variation

5. Assist in executing Product registration with MDA

• Medical device registration
• Special access application
• Change notification

6. Assist & coordinate company’s Halal & FOSIM applications

7. Assist in various company’s licenses renewal (MOH/NPRA/MDA/MBDK)

8. Assist in proper filing of RA/QA documents/records and administrative task

9. Assist in audit & inspection when necessary.

10. Any other task given/instruct by Immediate Supervisor or the Management

Pay: RM2,200.00 - RM2,500.00 per month

Benefits:

• Free parking

Work Location: In person