Kerja Sepenuh Masa QA Officer, Gaji tinggi MYR 3,000 di SM PHARMACEUTICALS SDN BHD Kedah - Maukerja

Job Description

1. Responsible for assisting and maintaining a system in accordance with Good Manufacturing Practice (GMP) and Good Distribution Practices (GDP) guidelines in all production areas and stores.

2. Responsible for online checking of all products and their respective Batch Manufacturing Records and Batch Packing Records.

3. Responsible for counter checking all In-Process and Finished Goods record books, all machine and equipment usage record books, status of all machines during and after use.

4. To assist in ensuring all products manufactured in all Production Departments are as per Good Manufacturing Practice guidelines and also as per master batch records and specifications.

5. Preparation, review and monitor the validation program as per the Validation Master Plan for equipment and utilities.

6. Responsible for the preparation and review of Annual Product Reviews (APR), Process Validations, Cleaning Validations, and Equipment Qualifications. This includes coordinating with relevant departments to ensure timely completion of protocols and reports, as well as handling the collection and delivery of related samples to the Quality Control (QC) department for analysis.

7. To liaise with relevant Regulatory Authorities in matters relating to Quality Assurance and cGMP in accordance with latest applicable guidelines.

8. To be responsible for the control and distribution of documents, which shall be carried out in accordance with the procedures outlined in the relevant SOP.

9. To ensure that all materials issued for manufacture of products are as per the requirements in the Batch Manufacturing Record.

10. Responsible for ensuring receipt, issuance and storage of all organization charts, lists

of personnel along with their job descriptions.

11. Responsible for the handling of status labels in all areas of manufacturing and equipment to ensure that the labeling always reflect the current correct status.

12. Responsible for ensuring good sanitation and plant hygiene practices as per the

requirement of Good Manufacturing Practices (GMP).

13. Coordinate with the Quality Risk Management Team to perform Quality Risk Management activities, including Failure Mode and Effects Analysis (FMEA) and Root Cause Analysis (RCA), in accordance with the established SOP.

14. To coordinate with the Production Manager, Quality Assurance Manager, Quality Control Manager, Engineering Manager to assure quality of the products.

15. To assist in Quality Control and Research and Development departments in special projects, technical development and technical support.

16To review in the implementation of artwork approval system and procedures.

17. Creation of the Raw Material and Packing Material codes in E-Soft software system and update the codes accordingly in approved vendor list.

18. Shall be responsible for the Vendor Management of raw materials, packaging materials and approved vendors.

19. To assist in carrying out product recall when required and to investigate the product complaints.

20. To help in the maintenance of all files related to the Quality Assurance Department.

21. To perform any other duties as assigned by the immediate superior

JOB REQUIREMENTS

EDUCATION

• Bachelor's Degree or Diploma in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Life Sciences, or a related field.

EXPERIENCE

• Minimum 1-2 years of experience in pharmaceutical regulatory affairs or product registration. Fresh graduates with relevant internship experience are encourage to apply.

Pay: RM1,800.00 - RM3,000.00 per month

Benefits:

• Meal allowance
• Professional development

Work Location: In person