QA Manager

Hirehub Management Sdn. Bhd.; Pasir Gudang; On-site; MYR 80,000 - 120,000; Full time

Job summary

A leading company in chemical production in Malaysia is seeking a Quality Assurance Specialist to manage quality systems, conduct audits, and ensure compliance with GMP and FDA regulations. The ideal candidate holds a Bachelor's degree and has over 5 years of experience in Quality Assurance, preferably in fine chemicals or pharmaceuticals. This is an excellent opportunity to join a reputable firm with a focus on quality control and compliance.

Qualifications

• 5+ years in Quality Assurance, preferably in fine chemicals or pharmaceuticals.
• Experience in a QC department handling FDA audits.

Responsibilities

• Establish and maintain quality management systems to ensure compliance.
• Oversee audits and ensure corrective actions.
• Verify product labeling and conduct final inspections.

Skills

Knowledge of GMP and US FDA regulations

Strong problem-solving skills

Analytical skills

Experience in audits

Education

Bachelor's degree in Chemical Engineering, Industrial Chemistry, or related field

Job description

Overview

Our client specializes in the research, development, production, and sales of daily chemical raw materials, including cosmetic active ingredients, raw materials, and synthetic perfumes. They operate two major production bases in Suqian City, Jiangsu Province, and Manshan City, Anhui Province. The Manshan City production base, through its subsidiary, was constructed according to GMP guidelines for APIs and has passed the FDA on-site audit.

Job Description

• Establish, implement, and maintain quality management systems to ensure efficiency and compliance with company needs.
• Oversee internal audits, customer audits, and third-party certifications, ensuring timely completion and corrective actions.
• Determine the disposition of raw materials, samples, and finished products based on quality checks.
• Address customer complaints, organize problem analysis, provide solutions, and follow up on resolutions.
• Participate in quality reviews of new products, technical modifications, and assess quality risks.
• Verify product labeling, batch combinations, and conduct final product inspections before shipment.
• Conduct onboarding and annual quality training for new employees.

Job Requirements

• Bachelors degree or higher in Chemical Engineering, Industrial Chemistry, or related field.
• 5+ years in Quality Assurance, preferably in fine chemicals or pharmaceuticals.
• Knowledge of GMP, US FDA regulations, and quality control processes. Strong problem-solving and analytical skills.
• Experience in a QC department, with familiarity in handling FDA audits.