健合集团
品类质量助理经理/经理-ANC
岗位职责
• Collaborate closely with cross-functional teams (including R&D, Sales & Marketing, Regulatory Affairs, and Sourcing) to ensure all New Product Development (NPD) and Existing Product Development (EPD) projects are executed according to established timelines, while maintaining robust quality and safety management to meet business objectives.
• Act as the Quality representative throughout the entire NPD/EPD process in accordance with company
任职要求
, overseeing activities such as new supplier development, raw material risk assessment, stability study review, pilot trial inspection, specification setting, Quality Assurance Agreement (QAA), and commercial production.
• Lead thorough investigations and follow-up actions for deviations, customer complaints, and non-conformances to ensure root causes are identified, and that effective Corrective and Preventive Actions (CAPA) are implemented, closed, and verified.
• Conduct regular and targeted audits and inspections of suppliers and contract manufacturers to ensure compliance with company quality standards and regulatory requirements, while identifying and driving continuous improvement opportunities.
• Oversee and ensure compliance in key quality processes, e.g. change control, customer complaint handling, and post-market product quality management.
• Initiate and drive continuous improvement program for products/processes with cross functional team and external parties (supplier, contract manufacturer, etc.).
• Initiate, review and complete the QAA, Specification and other technical files with suppliers and contract manufacturer.
• Set up and implement specific quality data analysis, summary and reporting.
• Perform other duties as required.
Knowledge and Skills Requirements
• Bachelor's degree or higher in Pharmaceutics, Food Science, Biology, Chemistry, or a related Page 2 of 2 discipline.
• At least 5 years of quality management experience in a highly regulated industry, with familiarity in regulatory frameworks such as TGA, FDA, FSANZ, or PIC/S.
• Demonstrated expertise in quality management systems, including ISO 9001, HACCP, and GMP.
• In-depth knowledge of regulatory compliance requirements specific to dietary supplements and food products.
• Strong analytical and problem-solving skills, with a proven ability to resolve complex quality related issues.
• Excellent communication and interpersonal skills, capable of working effectively with cross functional teams.
• Highly data/detail-oriented and organized, with a strong commitment to maintaining the highest standards of product quality and food safety.
• Able to work effectively under pressure in a fast-paced, dynamic environment, while maintaining a high standard of quality and making sound decisions.
• Fluent in written and spoken English, with the ability to use it as a working language.
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