QA Executive

Tiger Balm (Malaysia) Sdn Bhd; Kulai; On-site; MYR 78,000 - 100,000; Full time

Benefits offered by this job

Attractive remuneration

Career advancement opportunities

Learning environment

Safe working environment

Job summary

Tiger Balm (Malaysia) Sdn Bhd is seeking a Quality Assurance Executive to perform day-to-day QA activities to ensure GMP compliance, review batch records, and support product disposition. The role involves CAPA, deviation management, audits, and collaboration with cross-functional teams to uphold data integrity at our Kulai, Johor site.

The ideal candidate holds a Bachelor’s degree in a relevant discipline and at least 3 years in QA within GMP-regulated manufacturing.

Qualifications

• Bachelor’s degree in Chemistry, Biotechnology, Microbiology, Pharmacy, Quality Management, Engineering or related field.
• Minimum 3 years of relevant QA experience in pharmaceutical or GMP-regulated manufacturing.
• Strong knowledge of GMP, GDP, PIC/S and Quality Management Systems.
• Experience with deviations, CAPA, change control, risk management, investigation, and audit processes.
• Familiarity with batch record review and product release/disposition activities.
• Experience with qualification and validation activities and external regulatory audits (FDA, NPRA).
• Excellent analytical, problem-solving, and documentation skills; ability to work cross-functionally.

Responsibilities

• Perform day-to-day QA activities to ensure GMP compliance and adherence to QMS.
• Review and approve batch manufacturing records, packaging records, specs, procedures and protocols.
• Support batch release and product disposition with proper documentation.
• Manage deviations, investigations, CAPA, change controls, and quality risk assessments.
• Participate in root cause analysis and implement effective corrective actions.
• Conduct GMP and quality system inspections and follow up audit observations.
• Support self-inspections, regulatory inspections, customer and supplier audits.
• Review change controls, complaints, and other quality-related matters for impact and actions.
• Provide QA support to Production, QC, Engineering, Warehouse and other departments.
• Assist in the preparation, review and implementation of SOPs and quality procedures.
• Identify quality trends and opportunities for continuous improvement.
• Engage in quality improvement projects, validation/qualification activities.

Skills

GMP compliance

Quality Assurance

Audit readiness

CAPA management

Deviation management

Root cause analysis

Documentation

Quality risk assessment

Cross-functional collaboration

Analytical skills

Education

Bachelor’s Degree in Chemistry, Biotechnology, Microbiology, Pharmacy, Quality Management, Engineering

Job description

Perform day-to-day Quality Assurance activities to ensure compliance with GMP, company procedures, regulatory requirements, and the Quality Management System.

Review and approve batch manufacturing records, packaging records, specifications, procedures, protocols, and other GMP-related documents.

Support batch release and product disposition activities by ensuring all required documentation and quality requirements are satisfactorily completed.

Manage and follow up on deviations, investigations, CAPA, change controls, and quality risk assessments.

Participate in root cause analysis and investigation of quality issues and ensure appropriate corrective and preventive actions are implemented effectively.

Conduct GMP and quality system inspections/audits and support follow-up of audit observations and commitments.

Support self-inspections, regulatory inspections, customer audits, and supplier audits as required.

Review and assess change controls, complaints, and other quality-related matters to ensure appropriate impact assessment and actions.

Provide QA support to Production, QC, Engineering, Warehouse, and other departments on GMP and quality-related matters.

Support the preparation, review, and implementation of SOPs, work instructions, quality procedures, and other controlled documents.

Assist in identifying quality trends, recurring issues, and opportunities for continuous improvement.

Participate in quality improvement projects, validation/qualification activities, and other QA initiatives as assigned.

Maintain accurate and timely QA records and ensure activities are properly documented in accordance with GMP requirements.

Requirements

Bachelor’s Degree in Chemistry, Biotechnology, Microbiology, Pharmacy, Quality Management, Engineering, or other relevant disciplines.

Minimum 3 years of relevant experience in Quality Assurance, preferably within the pharmaceutical or other GMP-regulated manufacturing industry.

Good understanding of GMP, GDP, PIC/S and Quality Management Systems.

Knowledge of deviation, CAPA, change control, risk management, investigation, document control, and audit processes.

Familiarity with batch record review and product release/disposition activities is an added advantage.

Experience in qualification and validation activities, including review of relevant protocols, reports, and documentation, will be an added advantage.

Exposure to QC activities, laboratory operations, analytical testing, and QC-related investigations will be an added advantage.

Experience in supporting or participating in external regulatory audits/inspections, such as FDA and NPRA, will be an added advantage.

Experience in supporting regulatory inspections, customer audits, or internal/self-inspections will be an advantage.

Strong analytical, problem-solving, communication, and documentation skills.

Detail-oriented with a strong commitment to quality, compliance, and data integrity.

Able to work independently and effectively with cross-functional teams in a fast-paced manufacturing environment.

GMP & Regulatory Compliance

Quality Management Systems

CAPA & Deviation Management

Documentation & Data Integrity

Audit & Inspection Readiness

Problem Solving & Continuous Improvement

Cross-functional Collaboration

TIGER BALM (M) SDN BHD is an established company that manufactures markets and distributes high quality OTC pharmaceutical product. Nearly 100 years ago, a Chinese herbalist prepared an effective, fast-acting balm under a secret formula with all natural ingredients. One of its Tiger Balm is a brand leader in many overseas markets and is famous around the worlds.The production base moved from Burma to Singapore in 1926. From here the product was aggressively marketed and sold into many neighbouring countries. Today, Tiger Balm is world famous being sold in over 100 countries in 5 continents. Why join us? Attractive remuneration package. Excellence career advancement opportunity. Good learning environment We advocate safe working environment for all our employees.

What can I earn as a Quality Assurance Executive