Quality Assurance Executive

Position Title: Quality Assurance Executive

Workbase: Cheng, Melaka

Key Responsibilities:

1. Provides support Quality Management System operation, including change control, deviation, customer complaint, recall, CAPA management;
2. Support annual product quality review;
3. Support the investigation to non-conformance;
4. Support stability study management;
5. Review and approval of protocols and reports of qualification & validation, including equipment qualification, utilities qualification, analytical method validation, process validation, cleaning validation and so on;
6. Support on computerized system validation and implement GAMP5 requirement;
7. Support the implementation of Good Distribution Practice and Good Warehouse Practice;
8. Implement quality risk management;
9. Support on product toxicity assessment;
10. Support and provide QA oversight on good laboratory practice compliance;
11. Support on plant wide audit trail review;
12. Propose and execute quality improvement program;
13. Lead and coordinate projects and manage the deliverables effectively;
14. Develop skills to front auditors as SME/ supporting QA oversight;
15. Support in Supplier Quality Management System;
16. Governance of Pest Control/ Environmental Monitoring.

Minimum Requirements:

1. Degree in Pharmacy with minimum two years working experience, degree in Chemistry, Microbiology, Science or Engineering, with minimum two years (QA Executive II) and three years (QA Executive I) in the quality assurance, quality control or related functions in a manufacturing operation.
2. Experience in the management of Quality Assurance Programs for pharmaceutical and prior statistical background will be an added advantage.
3. Good knowledge of ISO and PIC/S regulations and cGMP is required.
4. Excellent interpersonal and communication skills (speaking and writing in English) and able to work independently.
5. Attention to detail, possess planning and organizing skills, critical thinking skills, judgment skills and decision-making skills.
6. Proficient in Microsoft office applications.