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Assistant QA Manager

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Onsite

Assistant QA Manager

HOE Pharmaceuticals Sdn Bhd

Assistant QA Manager

Skills

Testing & QAPerformance ManagementBudgetingComplianceRisk Management

2 months ago

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Important information


Contract type:

Permanent

Salary:

MYR 78,000 – MYR 90,000 / year

Location:

Kuala Selangor, Selangor, Malaysia

Work mode:

Onsite

Published on:

10 August 2026

What they need


Are you passionate about driving quality in pharmaceutical manufacturing? Do you have a strong foundation in GMP, a strategic mindset, and a hands-on leadership style? If yes, we invite you to join our team to lead, inspire, and make a real impact.

The Position

As the QA leader, you will be responsible for overseeing the full spectrum of Quality Assurance operations in a GMP-certified pharmaceutical manufacturing facility.

You will manage the QA team and ensure alignment with regulatory, corporate, and customer expectations — leading continuous improvement initiatives, ensuring compliance, and fostering a culture of quality.

Job Responsibilities:

·        Lead and manage the QA department to ensure robust implementation of Quality Management Systems (QMS), including Change Control, Product Quality Review, and Risk Management.

·        Serve as the Authorized Person for final product release, ensuring compliance with GMP and timely delivery aligned with production schedules.

·        Oversee and verify that all required validations, QC testing, batch record reviews, deviation management, and regulatory requirements are met prior to batch release.

·        Drive continuous improvement by reviewing SOPs, procedures, and processes, identifying gaps and implementing effective CAPAs.

·        Support regulatory submissions for product registrations by compiling relevant QA documentation (e.g., BMRs, CoAs).

·        Support departmental budgeting and resource planning to ensure alignment with operational needs, quality priorities, and continuous improvement initiatives.

·        Lead and support internal/external audits, ensuring CAPAs are effectively implemented and closed on time.

·        Monitor customer complaints and post-market surveillance data to drive quality enhancements.

·        Lead training, mentoring, and development of QA staff to build a high-performing team.

·        Report departmental KPIs and progress to senior management on a regular basis.

·        Collaborate across functions to support site quality goals and drive operational excellence.

Job Requirement

·        Bachelor's Degree in Chemistry, Microbiology, or related science discipline.

·        Minimum 5–7 years of QA experience in the pharmaceutical manufacturing industry.

·        Strong knowledge of GMP and regulatory expectations for pharma manufacturing.

·        Proven leadership skills with a track record of team development and performance management.

·        Excellent communication, analytical thinking, and problem-solving abilities.

·        Organized, proactive, and able to manage multiple priorities with a sense of urgency.

·        Competent in writing technical reports and audit documentation.

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