Assistant Manager, SQA

Job Description

1. Supplier audit CAPA verification, supplier onboarding, quality system and process improvement (20%)

• Review supplier quality audit findings and verify CAPA plan implementation with suppliers to improve their system and process.
• Manage supplier onboarding process to educate suppliers on ELC quality requirements identified in the supplier onboarding materials (Quality Agreement, Quality Manual, policy, procedures, specifications, GQMS, etc.), and drive supplier to evaluate the gaps and develop action plan to mitigate the risks.
• Drive continuous improvement initiatives with suppliers to improve their system and process to ensure compliance with Estee Lauder Quality Requirements including regulatory requirements (cGMP, ISO, etc.).

1. Product Launch Quality Management (40%)

• Work with suppliers to ensure new product launch program is established for each new product.
• Review Design / Process risk assessment conducted by supplier by using DFEMA / PFMEA.
• Review specifications for new products, ensure critical quality attributes (CQA) is identified.
• Review Quality Inspection Plan prepared by supplier for new products, ensure quality requirements in all stage (Incoming materials, WIPs, and Finished Goods) comply to ELC Product Specification Requirements.
• Review process flow designed by supplier for new products
• Review critical process parameters (CPP) identified by supplier to ensure CQA compliance
• Manage start-up validation for new product, verify the outputs and CAPA plan.
• Review in-process results and improvement actions
• Manage ELC FQC and ensure CAPA plan for detected issues are in place from system and process standpoint.
• Institutionalize continuous improvement by 1) improving robustness of specification, 2) Using Statistical Process Control (SPC) and Process Capability Tools, 3) Using risk assessment tools such as DFMEA, PFMEA.
• Ensure Change Management Practice (on design / process / material / facilities etc) is properly developed in Supplier QMS.
• Monitor existing product quality and work with suppliers to improve it.

1. Quality Problem Solving (20%)

• Communicate quality issues to supplier, review and validate corrective actions and preventive actions, ensure effective measures are implemented in manufacture process and quality systems.
• Systemize key QA processes to drive robust root cause analysis, and systemic process improvements that prevent reoccurrences, detect issues earlier and provide for contingency planning.

1. Supplier Performance Management (10%)

• Review supplier performance and compliance status on periodical basis, drive supplier continuous improvement plan.
• Ensure supplier has a robust Change Control Management process in place.

1. Improvement Projects (10%)

• Participate in global or regional quality improvement projects.
• Identify improvement opportunities to support global quality strategy.

• Strong ownership, leadership, interpersonal, communications and presentation skills.
• Supplier qualification: Quality management systems (QMS), QMS audit, audit CAPA follow-up, supplier onboarding, SPC, CPK, ISO9000, ISO22716, cGMP, process mapping, process validation, system validation, etc.
• New product quality management such as DFMEA, PFMEA, APQP and PPAP, etc.
• Deviation management (source containment, root cause analysis, CAPA, etc.)
• Improvement projects: be experienced to lead continuous improvement projects.
• Knowledge of packaging material is preferable
• Experience in working in manufacturing site (Cosmetic, Pharmaceutical and Food & Beverage industry) is preferable
• Knowledge of cosmetic related regulation and guideline in local is preferable

Familiar with Microsoft Office applications including Word, Excel, PowerPoint, Teams, etc.