QA Executive

Tiger Balm; Kulai; On-site; MYR 70,000 - 90,000; Full time

Job summary

Jora Malaysia is seeking a Quality Assurance professional to ensure GMP compliance and support regulatory readiness across production and QA functions.

You will review batch records, support product disposition, and lead deviation CAPA processes in a fast-paced manufacturing environment.

Qualifications

• Bachelor’s degree in relevant scientific or quality discipline.
• Minimum 3 years of QA experience in pharmaceutical GMP environments.
• Strong knowledge of GMP, GDP, PIC/S and QMS.
• Experience with deviation, CAPA, change control and risk management.
• Experience with batch record review and product release.
• Exposure to external regulatory audits/inspections (FDA/NPRA) is a plus.
• Excellent analytical, problem-solving, and documentation skills.
• Ability to work independently and with cross-functional teams.

Responsibilities

• Perform day-to-day Quality Assurance activities to ensure GMP compliance.
• Review and approve batch records, specifications, procedures and related documents.
• Support batch release and product disposition activities.
• Manage deviations, investigations, CAPA, change controls and risk assessments.
• Participate in root cause analysis and corrective actions.
• Conduct GMP and quality system inspections/audits and follow-up.
• Support regulatory and customer audits as required.
• Review change controls, complaints, and quality matters for impact assessment.
• Provide QA support to Production, QC, Engineering, Warehouse, and others.
• Assist in SOPs and controlled document preparation and implementation.
• Identify quality trends and opportunities for improvement.
• Participate in QA projects, validation/qualification activities, and audits.

Skills

Quality Assurance expertise

Regulatory compliance

Documentation and record-keeping

Audit readiness

Root cause analysis

Cross-functional collaboration

Analytical thinking

Education

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

Tools

Batch record review

Deviation management

CAPA processes

Job description

Jora Malaysia will close on 16th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

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