Quality Manager

Responsibilities:

1. Prepare, liaise with and follow-up on the audit conducted by National Pharmaceutical Regulatory Agency (NPRA) and other regulatory bodies (such as JAKIM/ JKKP) to maintain the company licensing compliance.
2. Oversee, organize and manage the QA/ QC department to ensure that product quality complies with regulatory requirements and company objectives.
3. Establish proper documentation control & implementation of QA/ QC procedures, and SOP to ensure compliance with GMP system.
4. Review, approve or reject the release of all raw materials which need to be used for production based on the lab test results/ product specification.
5. On-hold non-conforming products from further processing or shipment to customers and advise disposition of non-conforming product to Management if necessary.
6. Responsible for the final release of finished products.
7. Lead the QA/ QC department and work closely with other departments on troubleshooting product quality issues and process control optimization.
8. Work with Production/ Maintenance Department to ensure that execution of qualification and validation of production equipment or process is in compliance with regulatory GMP requirements.
9. Analyse, prepare and review the Product Quality Review (PQR) report, Verification/ Validation report.
10. Liaise with and give advice to Purchasing Department on all matters pertaining to the existing materials’ quality or newly introduced materials.
11. Monitor the performance of suppliers and service providers through evaluations or site audits.
12. Responsible for Product Complaint and Recall.
13. Liaise with the Marketing and Sales team on customer complaints to ensure that investigation and corrective actions are carried out in a proper and timely manner.
14. Conduct internal audits and monitor corrective actions to rectify non-compliance matters.
15. Analyse, review and justify the test frequency on samples to ensure acceptable and confidence level of results.
16. Establish training programs for QA/ QC personnel periodically.
17. Conduct in-house training on GMP and personal hygiene practices for all production personnel.
18. Assist in R&D for the implementation of improved formulas and new product development projects.
19. Perform any other tasks assigned by superiors.

Job Requirements:

1. Bachelor's/ Diploma in Pharmaceutical/Food Technology/ Science/ Biology/ Chemistry, with a minimum of 4 years in the related field required for this position.
2. Preferably Assistant Managers/ Managers specializing in Quality Control/ Assurance or equivalent.
3. Required language(s): English, Mandarin, Malay.
4. Knowledgeable about Pharmaceutical Good Manufacturing Practices (GMP), local authority regulations, safety procedures and managerial tactics.