- Port Klang Selangor Malaysia
Working Location
Job Description
Responsibilities
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.
Pay: RM6,500.00 - RM7,500.00 per month
Benefits:
Work Location: In person
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