QA Officer

2 days ago

Johor Bahru, Johor, Malaysia Sunward Pharmaceutical Sdn. Bhd. Full time 30,000 - 60,600 per year

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.

Job Types: Full-time, Permanent

Pay: RM2, RM3,500.00 per month

Benefits:

  • Free parking
  • Health insurance
  • Maternity leave
  • Opportunities for promotion
  • Professional development

Ability to commute/relocate:

  • Johor Bahru (Johor Bahru, 80500): Reliably commute or planning to relocate before starting work (Required)

Education:

  • Bachelor's (Required)

Experience:

  • QA: 1 year (Required)

Work Location: In person

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