MAIN OBJECTIVE OF THE JOB:

To support the Commercial Quality (CQ) operations for Malaysia, Singapore, Indonesia and Brunei by assisting in quality operations, data analysis, documentation management, quality system activities, and continuous improvement initiatives. The role provides exposure to pharmaceutical quality management systems while ensuring timely and compliant execution of day-to-day CQ activities.

DUTIES AND RESPONSIBILITIES:

Quality Operations Support

Support the intake and tracking of Event and Complaint records in the relevant quality systems.

Assist in monitoring case progress and ensuring timely follow-up with internal stakeholders and external partners.

Support compilation and review of documentation required for investigations and quality assessments.

Data Management and Analysis

Maintain quality-related databases, trackers, and records to ensure data accuracy and completeness.

Assist in performing complaint and event trending analyses to identify recurring issues and potential quality risks.

Support data collection and analysis for Quality Management Review (QMR) and other quality reporting activities.

Quality System Support

Assist in maintaining quality system documentation, including SOPs, work instructions, training records, and quality agreements.

Support document control activities, ensuring proper filing and archival of quality records.

Assist in tracking CAPA, change control, and supplier-related activities as assigned.

Support preparation of materials and documentation for audits, inspections, and quality reviews.

Administrative Support

Assist in scheduling meetings, preparing meeting materials, and documenting meeting minutes where required.

Support general administrative tasks related to Commercial Quality operations.

Perform other duties and projects as assigned by the Commercial Quality Lead.

TECHNICAL SKILLS REQUIRED

Proficient in Microsoft Office applications, particularly Excel and PowerPoint.

Possess analytical skills with the ability to interpret data and identify trends.

Basic understanding of data management, reporting, and documentation practices.

Interest in pharmaceutical quality systems, GxP requirements, and regulatory compliance.

SOFT SKILLS REQUIRED

Strong organizational and time management skills.

Good verbal and written communication skills in English.

Detail-oriented and attention to details.

Proactive, responsible, and willing to take ownership of assigned tasks.

Team player with the ability to collaborate effectively with cross-functional stakeholders.

Positive attitude and willingness to learn new systems and processes.

POSITION REQUIREMENTS / QUALIFICATIONS:-

Bachelor's Degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, Biomedical Science, or related disciplines.

Experience using Microsoft Excel for data analysis and reporting.

Familiarity with quality management systems, complaint handling, CAPA, or audit processes.

Knowledge of GxP and pharmaceutical regulatory requirements.

Experience in project coordination, data trending, or process improvement activities

Commercial Quality Assistant (Protege)