Quality Assurance Executive

Xepa-Soul Pattinson (Malaysia) Sdn Bhd; Melaka; On-site; MYR 30,000 - 60,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Executive to enhance their Quality Management System in a dynamic environment. This role involves supporting various QA functions, including managing audits, overseeing compliance with Good Distribution Practice, and implementing quality improvement programs. The ideal candidate will possess a degree in Pharmacy or a related field, along with experience in quality assurance within a manufacturing context. Join this forward-thinking company and contribute to maintaining high-quality standards in the pharmaceutical industry, where your skills and attention to detail will play a crucial role in ensuring product safety and compliance.

Qualifications

• Degree in Pharmacy or related field with relevant QA experience.
• Good knowledge of ISO and PIC/S regulations and cGMP.

Responsibilities

• Support Quality Management System operations and audits.
• Implement quality risk management and improvement programs.
• Lead projects and manage deliverables effectively.

Skills

Quality Assurance

Attention to Detail

Communication Skills

Critical Thinking

Decision-Making

Education

Degree in Pharmacy

Degree in Chemistry

Degree in Microbiology

Degree in Science or Engineering

Tools

Microsoft Office

Job description

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.