QA Lead, GMP Pharma — Quality & Compliance

HOE Pharmaceuticals Sdn Bhd; Bandar; On-site; IDR 783,904,000 - 1,045,205,000; Full time

Job summary

Jora Malaysia is seeking a QA leader to oversee quality assurance in a GMP‑certified pharmaceutical manufacturing facility. You will manage the QA team, ensure compliance with regulatory and customer expectations, and drive continuous improvement.

The role requires a bachelor’s degree in sciences and 5–7 years QA experience, strong leadership skills, and excellent communication. You will participate in audits, CAPAs, and support product quality release.

Qualifications

• Bachelor's degree in Chemistry, Microbiology, or related science.
• Minimum 5–7 years of QA experience in the pharmaceutical manufacturing industry.
• Strong knowledge of GMP and regulatory expectations for pharma manufacturing.
• Proven leadership 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 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.

Skills

GMP knowledge

Leadership

Analytical thinking

Problem solving

Education

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

Job description

Jora Malaysia is seeking a QA leader to oversee quality assurance in a GMP‑certified pharmaceutical manufacturing facility. You will manage the QA team, ensure compliance with regulatory and customer expectations, and drive continuous improvement.

The role requires a bachelor’s degree in sciences and 5–7 years QA experience, strong leadership skills, and excellent communication. You will participate in audits, CAPAs, and support product quality release.