HOE Pharmaceuticals Sdn Bhd
Assistant QA Manager
Skills
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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