Senior Executive Quality Assurance

Xepa-Soul Pattinson (Malaysia) Sdn Bhd; Malacca City; On-site; MYR 80,000 - 140,000; Full time

Job summary

Xepa-Soul Pattinson (Malaysia) Sdn Bhd is seeking a Quality Assurance professional to ensure GMP compliance across suppliers, artwork management, contract manufacturing and finished goods return processes. You will review supplier quality agreements, monitor performance and drive CAPA closures.

The role requires a degree in Pharmacy, Chemistry, Microbiology, Science or Engineering with at least five years’ experience in QA/QC in manufacturing, plus knowledge of ISO/PIC/S regulatory requirements

Qualifications

• Degree in Pharmacy, Chemistry, Microbiology, Science or Engineering with at least five years in QA/QC in manufacturing.
• Experience in quality investigations, deviation management, and CAPA implementation.

Responsibilities

• Ensure GMP compliance across suppliers and materials.
• Review supplier quality agreements and monitor supplier performance.
• Coordinate artwork revision and maintain approved artwork in systems.
• Release and quality-review contract-manufactured finished goods.
• Manage return of finished goods with proper documentation and traceability.
• Support internal and external audits and continuous improvement.

Skills

Attention to detail

Planning & organizing

Communication skills

Independent worker

Education

Bachelor's degree in Pharmacy, Chemistry, Microbiology, Science or Engineering

Tools

Microsoft Office

Job description

Duties and Responsibilities:

• 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.
• 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.
• Experience in the management of Quality Assurance Programs for pharmaceutical and prior statistical background will be an added advantage.
• Good knowledge of ISO and PIC/S regulations and cGMP is required.
• Excellent interpersonal and communication skills (speaking and writing in English) and able to work independently.
• Attention to detail, possess planning and organizing skills, judgment skills and decision-making skills.
• Proficient in Microsoft Office applications.