品質體系經理

Hong Kong Trace Elements Health Technology Company Limited; Sha Tin; On-site; HKD 600,000 - 900,000; Full time

Job summary

Hong Kong Trace Elements Health Technology Company Limited is seeking a Quality Assurance/Quality Control leader to establish and maintain a comprehensive quality system supporting nutrition, dietary supplements and pharmaceutical products. You will drive GMP compliance, SOPs, audits, and regulatory readiness across the full supply chain.

Responsibilities include leading internal audits, coordinating government inspections, maintaining certifications, and collaborating with departments to ensure

Qualifications

• Bachelor's degree or higher in a relevant field (e.g., Food Science/Pharmacy).
• At least 3 years of quality management experience in the nutrition foods, dietary supplements, food industry, or pharmaceutical sector.
• Familiarity with quality management systems and mastery of GMP-related requirements; experience establishing quality systems for nutritional foods or dietary supplements is preferred; understanding regulatory requirements set by HK authorities is preferred.
• Comprehensive practical experience across the full supply chain: supplier audit, deviation management, CAPA, complaints, recalls, non-conforming product handling.

Responsibilities

• Establish and maintain a comprehensive quality system (SOPs, Quality Manual, records).
• Lead implementation, training, monitoring, internal audits and management reviews.
• Coordinate third-party and government audits and follow-up rectification in a closed-loop system.
• Maintain quality certifications and assist in license applications and annual audits.
• QA management: quality audit of supplied goods; product release, CAPA, complaints and recalls; incident handling and closure of corrective actions.
• QC management: establish QC controls; coordinate with external testing agencies and Supervisory Inspection Process.
• Collaborate with other departments to ensure export product compliance and mitigate business risks.

Skills

Quality management

GMP compliance

SOP development

Audits

Regulatory understanding

Education

Bachelor's degree in Food Science/Pharmacy

Job description

Job Responsibilities

I. Establishment and Maintenance of the Quality System: Establish a comprehensive quality management system, including Standard Operating Procedures (SOPs), a Quality Manual, and record forms, covering the entire quality management process.

2. Lead the implementation of the quality management system, organize training sessions, monitor execution, and conduct internal audits and management reviews.

3. Integrate third-party and government official audits and follow-up rectification processes into a closed-loop system.

4. Maintain quality certifications and record-keeping; assist in preparing for license applications, annual audits, and other related procedures.

II. QA Management

1. Responsible for the quality audit and assessment of supplied goods, and for establishing a quality management system for supplied goods.

2. Product release, deviation CAPA, complaints and recalls; establish an incident handling mechanism and follow up on the closure of corrective actions.

3. Responsible for file version management.

III. QC Management

1. Establish a QC control mechanism to coordinate inspection and quality control activities; collaborate with external third-party testing agencies.

2. Implementation of the Supervisory Inspection Process.

IV. Collaborate with other departments to ensure export product compliance requirements are met and to mitigate business risks.

Job Requirements:

1. Bachelor's degree or higher in a relevant field (e.g., Food Science/Pharmacy);

2. At least 3 years of experience in quality management within the nutritional foods, dietary supplements, food industry, or pharmaceutical sector.

Familiarity with quality management systems and mastery of GMP-related requirements; experience in establishing quality management systems for nutritional foods or dietary supplements is preferred; understanding of the regulatory requirements set by the Food and Environmental Hygiene Department and the Health Bureau is also preferred.

3. Proficient in overseeing comprehensive system development, QA, and QC management across startups; possesses practical expertise in independently establishing operational frameworks, drafting SOPs, conducting internal audits, and responding to government regulatory inspections.

4. Possess comprehensive practical experience across the entire supply chain process, including supplier audit, deviation management, CAPA implementation, customer complaints and product recall handling, and non-conforming product management.

5. Strong proficiency in both Chinese and English reading and writing skills; ability to read and interpret English regulatory documents and reporting files issued by the Hong Kong Government; Cantonese communication skills are preferred.

6. Possesses strong project execution capabilities, the ability to adapt to the multifaceted operations of a startup, and excellent communication and coordination skills.

7. Hong Kong residency; full-time office location in Hong Kong; occasional travel to the Guangzhou Group headquarters for meetings and collaboration is required.