Responsibilities
System Framework Responsibilities
- Set and maintain the company Quality and Safety System Management
- Document and enforce manufacturing standards and expectations (e.g., traceability, sanitization, GMP).
- Prepare documents for internal and external quality audits and maintenance of line control equipment files.
- Support projects on quality and safety risk assessment and mitigation actions.
- Assess and report compliance together with the company Quality and Safety system (e.g., audit policies for vendors, external and internal manufacturing sites, and relevant supply chain functions).
- Identify continuous improvement opportunities for performance and efficiency, and implement fit-for-purpose initiatives.
- Lead and support the Issue and Crisis teams for major events involving manufacturing sites and external partners
- Develop and maintain compliance standards for the QA organization.
- Set standards and expectations for the company’s QA.
- Partner with internal stakeholders & external stakeholders, ensuring continuous control over materials, facilities, and products.
Manufacturing Responsibilities
- Manage and lead Quality Control operations.
- Ensure high consistent quality standards and enforce stringent control processes.
- Introduce up-to-date monitoring of factory operations to ensure quality compliance.
- Lead investigations for defective quality issues raised by customers, especially key customers.
- Establish root causes and implement effective corrective actions to prevent mistakes.
- Lead the Quality Team, ensuring overall manufacturing quality function and compliance.
- Plan upgrades for advanced QC test equipment and reliable software technology.
Requirements
- Experience in the Manufacturing industry, with experience in Manufacturing Quality Management, GMP knowledge, Analytical Skills, Manufacturing & Control Analysis, Root Cause Analysis
- Strong in Quality Systems, Quality Assurance/Quality Control, environmental and regulatory parameters, Problem Solving, and Team Player.
- Bachelor’s degree in Quality, Mechanical or Industrial Engineering or equivalent combination of experience and education. Over 5-8 years of experience in Quality, Process Improvement, Manufacturing, or equivalent.
- Proven experience in handling Issues and Crises
Account Manager
Kerwin Tan Kai Bin (R1331624)
EA16S8107