QA Officer

Sunward Pharmaceutical; Johor Bahru; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading pharmaceutical company in Johor Bahru is seeking a Quality Management professional. Responsibilities include maintaining compliance with GMP/ISO standards, overseeing batch release processes, and assisting in validation activities. The ideal candidate holds a Bachelor’s Degree in Science or a related field, possesses knowledge of Quality Management Systems, and has excellent documentation handling skills. Fresh graduates are encouraged to apply.

Qualifications

• Minimum Bachelor’s Degree or Professional Degree in Science, Pharmaceutical, or equivalent.
• Knowledge of Quality Management Systems (e.g. GMP, ISO9001) is an added advantage.
• Understanding of Qualification & Validation processes is an added advantage.

Responsibilities

• Maintain and update the Quality Management System in compliance with GMP/ISO requirements.
• Review batch manufacturing records and QC test results for compliance.
• Assist in planning and executing validation activities.

Skills

Knowledge of Quality Management Systems

Excellent communication skills

Documentation handling

Education

Bachelor’s Degree in Science or Pharmaceutical

Job description

1. Quality Management System (QMS)

• Maintain and update the Quality Management System in compliance with GMP/ISO requirements.
• Review, revise, and control Standard Operating Procedures (SOPs) and quality documents.
• Manage Change Control, Deviation, CAPA, and Complaint handling processes.
• Assist in coordinating internal and external audits, including audit preparation and follow‑up actions.
• Ensure proper document control, record traceability, and compliance with regulatory standards.

2. Batch Release

• Review batch manufacturing records, batch packing records, and QC test results.
• Verify that all production and testing activities meet GMP and quality specifications before release.
• Identify discrepancies or non‑conformities and ensure timely investigation and closure.
• Coordinate with Production, QC, and Warehouse for batch‑related issues.
• Support in preparing batch release documentation for approval by the Qualified Person (QP) or QA Manager.

3. Validation

• Assist in planning and executing validation activities, including equipment qualification (IQ/OQ/PQ), process validation, and cleaning validation.
• Prepare and review validation protocols and reports.
• Monitor equipment calibration, preventive maintenance, and requalification schedules.
• Ensure validation activities comply with regulatory and internal quality standards.
• Maintain validation records and support continuous improvement of validation systems.

Requirements

• Minimum Bachelor’s Degree or Professional Degree in Science, Pharmaceutical, or equivalent.
• Knowledge of Quality Management Systems (e.g. GMP, ISO9001) is an added advantage.
• Understanding of Qualification & Validation processes is an added advantage.
• Well‑versed in documentation handling.
• Excellent communication and writing skills.

Fresh graduates are encouraged to apply.