Quality Assurance Executive

The Company

Tiger Balm Malaysia, a part of the Haw Par Group, is a leader in many overseas markets and is renowned worldwide. We are an established and progressive company that manufactures, markets, and distributes high-quality OTC and ethical pharmaceutical products. Known for its effective herbal remedies, Tiger Balm has been trusted for over a century to provide relief from muscle aches, joint pain, and headaches with natural ingredients.

The Role

We are seeking a QA Executive to support day-to-day Quality Assurance activities and ensure compliance with GMP, regulatory requirements, company procedures and the Quality Management System.

Key Responsibilities:

1. Perform day-to-day Quality Assurance activities to ensure compliance with GMP, company procedures, regulatory requirements, and the Quality Management System.
2. Review and approve batch manufacturing records, packaging records, specifications, procedures, protocols, and other GMP-related documents.
3. Support batch release and product disposition activities by ensuring all required documentation and quality requirements are satisfactorily completed.
4. Manage and follow up on deviations, investigations, CAPA, change controls, and quality risk assessments.
5. Participate in root cause analysis and investigation of quality issues and ensure appropriate corrective and preventive actions are implemented effectively.
6. Conduct GMP and quality system inspections/audits and support follow-up of audit observations and commitments.
7. Support self-inspections, regulatory inspections, customer audits, and supplier audits as required.
8. Review and assess change controls, complaints, and other quality-related matters to ensure appropriate impact assessment and actions.
9. Provide QA support to Production, QC, Engineering, Warehouse, and other departments on GMP and quality-related matters.
10. Support the preparation, review, and implementation of SOPs, work instructions, quality procedures, and other controlled documents.
11. Assist in identifying quality trends, recurring issues, and opportunities for continuous improvement.
12. Participate in quality improvement projects, validation/qualification activities, and other QA initiatives as assigned.
13. Maintain accurate and timely QA records and ensure activities are properly documented in accordance with GMP requirements.

Requirements:

1. Bachelor's Degree in Chemistry, Biotechnology, Microbiology, Pharmacy, Quality Management, Engineering, or other relevant disciplines.
2. Minimum 3 years of relevant experience in Quality Assurance, preferably within the pharmaceutical or other GMP-regulated manufacturing industry.
3. Good understanding of GMP, GDP, PIC/S and Quality Management Systems.
4. Knowledge of deviation, CAPA, change control, risk management, investigation, document control, and audit processes.
5. Familiarity with batch record review and product release/disposition activities is an added advantage.
6. Experience in qualification and validation activities, including review of relevant protocols, reports, and documentation, will be an added advantage.
7. Exposure to QC activities, laboratory operations, analytical testing, and QC-related investigations will be an added advantage.
8. Experience in supporting or participating in external regulatory audits/inspections, such as FDA and NPRA, will be an added advantage.
9. Experience in supporting regulatory inspections, customer audits, or internal/self-inspections will be an advantage.
10. Strong analytical, problem-solving, communication, and documentation skills.
11. Detail-oriented with a strong commitment to quality, compliance, and data integrity.
12. Able to work independently and effectively with cross-functional teams in a fast-paced manufacturing environment.