Asisstant QA Manager

HOE Pharmaceuticals Sdn Bhd; Port Klang; On-site; MYR 180,000 - 240,000; Full time

Job summary

HOE Pharmaceuticals Sdn Bhd is seeking an experienced QA leader to head the QA department in Port Klang. You will ensure robust QMS implementation, supervise product release as Authorized Person, and drive continuous improvement across QA activities.

The role requires strategic oversight of validations, QC testing, batch records, deviation management, and regulatory submissions. You will mentor QA staff, report KPIs to senior management, and collaborate to uphold site quality goals.

Qualifications

• 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.

Responsibilities

• Lead and manage the QA department to ensure robust QMS implementation, including Change Control, Product Quality Review, and Risk Management.
• Serve as the Authorized Person for final product release, ensuring GMP compliance and timely delivery aligned with production schedules.
• Oversee and verify validations, QC testing, batch record reviews, deviation management, and regulatory requirements before batch release.
• Drive continuous improvement by reviewing SOPs, procedures, and processes, identifying gaps and implementing 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.

Skills

Leadership

Quality Management

Communication

Analytical thinking

Problem-solving

Education

Bachelor's Degree in Chemistry, Microbiology, or related science

Tools

GMP knowledge

Job description

Jora Malaysia will close on 9th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

• 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.