Senior Executive Quality Assurance

Position: Senior Quality Assurance Executive (SQM)

Work Base: Cheng, Melaka

Duties and Responsibilities:

1.Vendor Management

• Ensure effective control and qualification of raw materials and packaging materials from approved suppliers.
• Review and maintain Supplier Quality Agreements and monitor supplier performance.
• Support supplier evaluation and re-evaluation based on risk, quality performance, and regulatory compliance.

2.Artwork Management

• Coordinate artwork revision, review, and approval with relevant stakeholders and vendors.
• Control and maintain approved artwork in the relevant electronic systems to ensure correct implementation.
• Ensure artwork changes are reflected in the latest versions of packaging instructions and that obsolete versions are properly archived.

3.Contract Manufacturing Product Management

• Perform quality reviews of documentation related to contract-manufactured products.
• Ensure timely and compliant release of contract-manufactured finished goods.
• Coordinate with contract manufacturers on quality complaints, investigations, and CAPA closure.

4.Finished Goods Return Management

• Manage the return of finished goods, including evaluation, investigation, and final disposition.
• Maintain proper documentation and traceability of returned goods in accordance with GMP requirements and company procedures.

5.Quality Documentation and Compliance

• Ensure relevant SQM activities and documentation comply with GMP, regulatory requirements, and established company procedures.
• Support quality investigations, deviation management, and CAPA implementation related to suppliers, artwork, contract manufacturing, and returned finished goods.
• Report quality issues, non-conformances, and anomalies to the relevant stakeholders in a timely manner.

6.Continuous Improvement and Audit Support

• Support internal and external audits related to SQM activities.
• Monitor quality performance and identify opportunities for improvement in supplier management, artwork control, contract manufacturing, and finished goods return processes.
• Support the implementation and continual improvement of applicable quality management systems and ISO standards.

Minimum Requirements:

1. Preferably Degree in Pharmacy, Chemistry, Microbiology, Science or Engineering, with at least five (5) years of working experience in Quality Assurance, Quality Control, or related functions within a manufacturing environment.
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, judgment skills and decision-making skills.
6. Proficient in Microsoft Office applications.