Quality Manager || FDA Audits || Pasir Gudang

Company Background:

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 Ma'anshan City, Anhui Province. The Ma'anshan 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 Requirement:

• 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.

Salary Range:

• Open for discussion

Job Types: Full-time, Permanent

Pay: RM13,000.00 - RM18,000.00 per month

Benefits:

• Opportunities for promotion
• Professional development

Schedule:

• Monday to Friday

Supplemental Pay:

• Performance bonus
• Yearly bonus

Experience:

• FDA Audits: 1 year (Preferred)
• QA/QC: 1 year (Preferred)
• QMS: 1 year (Preferred)

Language:

• Mandarin (Preferred)