QAQC Manager || FDA Audits & Regulations || Pasir Gudang

Key Responsibilities:

• Lead and manage preparation for FDA inspections and audits, ensuring all regulatory requirements are met.
• Ensure that all documentation required for FDA audits is accurate and up to date.
• Develop, implement, and maintain the QMS to ensure compliance with internal and external standards.
• Oversee product lifecycle quality and regulatory compliance.
• Monitor product quality metrics and lead continuous improvement initiatives.
• Review and approve documentation related to product specifications, batch records, validation, and manufacturing procedures.
• Ensure compliance with international regulations and industry standards, including ISO13485 and other relevant quality certifications.
• Lead, mentor, and train a team of quality assurance specialists, providing guidance on best practices for product quality and compliance.
• Organize and conduct training on FDA regulations, GMP, and chemical safety for employees across the organization.
• Identify potential quality risks and lead efforts to mitigate them.
• Drive continuous improvement initiatives within the Quality Assurance and manufacturing operations.
• Conduct internal audits and lead investigations into quality incidents, ensuring all actions taken align with industry best practices and regulatory guidelines.

Job Requirement:

• Bachelors degree or higher in Chemical Engineering, Industrial Chemistry, or related field.
• 5+ years in Quality Assurance, preferably in chemicals industry.
• 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.

Job Types: Full-time, Permanent

Pay: RM9,000.00 - RM15,000.00 per month

Benefits:

• Opportunities for promotion
• Professional development

Schedule:

• Monday to Friday

Supplemental Pay:

• 13th month salary
• Performance bonus

Experience:

• FDA Audits: 1 year (Preferred)
• Chemical Manufacturing: 1 year (Preferred)
• GMP: 1 year (Preferred)
• ISO13485: 1 year (Preferred)

Language:

• Mandarin (Preferred)