Senior QA QC Executive

Ominent Sdn.Bhd.; Selangor; On-site; MYR 60,000 - 90,000; Full time

Job summary

Ominent Sdn.Bhd. seeks a Quality Assurance professional to develop, maintain, and improve the QMS in line with ISO 9001, GMP, and customer requirements. You will lead internal audits, support external audits, and ensure quality records are properly managed.

You will oversee inspection and testing of materials and finished products, develop validation methods, and drive CAPA and RCA investigations to reduce defects across Production, R&D, and Procurement. Strong collaboration is essential.

Qualifications

• Develop, maintain, and improve the QMS in compliance with ISO 9001, GMP, customer requirements, and applicable regulations.
• Lead internal audits, support external audits, and ensure quality documents such as SOPs, specifications, checklists, and quality records are properly maintained and updated.
• Lead investigations of quality issues, non-conformances, and deviations through Root Cause Analysis (RCA), implement CAPA, and monitor corrective action effectiveness.
• Oversee the inspection and testing of raw materials, in-process samples, and finished products, including chemical and analytical testing, to ensure compliance with specifications.
• Develop and validate testing methods, manage calibration and validation of laboratory equipment, and ensure the accuracy, reliability, and traceability of test results.
• Analyze quality data and trends, identify improvement opportunities, and work with Production, R&D, Procurement, and other departments to improve product consistency and reduce defects.
• Lead customer complaint investigations, provide technical recommendations, and work with suppliers to ensure incoming materials meet quality and performance requirements.

Responsibilities

• Lead audits and ensure quality records are up to date.
• Develop testing methods and validate laboratory equipment.
• Monitor test results for accuracy and traceability.
• Drive continuous quality improvement across departments.
• Manage customer and supplier quality investigations and compliance.

Skills

Quality Management

Audits

CAPA

RCA

Quality Documentation

Laboratory Testing

Analytical Methods

Calibration & Validation

Process Improvement

Supplier Quality

Customer Quality

Tools

ISO 9001

GMP

Job description

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Quality Management System & Compliance: Develop, maintain, and improve the QMS in compliance with ISO 9001, GMP, customer requirements, and applicable regulations.

Audits & Quality Documentation: Lead internal audits, support external audits, and ensure quality documents such as SOPs, specifications, checklists, and quality records are properly maintained and updated.

CAPA, RCA & Non-Conformance: Lead investigations of quality issues, non-conformances, and deviations through Root Cause Analysis (RCA), implement CAPA, and monitor corrective action effectiveness.

Quality Inspection & Laboratory Testing: Oversee the inspection and testing of raw materials, in-process samples, and finished products, including chemical and analytical testing, to ensure compliance with specifications.

Analytical Methods & Equipment: Develop and validate testing methods, manage calibration and validation of laboratory equipment, and ensure the accuracy, reliability, and traceability of test results.

Process & Product Quality Improvement: Analyze quality data and trends, identify improvement opportunities, and work with Production, R&D, Procurement, and other departments to improve product consistency and reduce defects.

Customer & Supplier Quality Management: Lead customer complaint investigations, provide technical recommendations, and work with suppliers to ensure incoming materials meet quality and performance requirements.