Manager, QA & Technical Support

Knowledge/Skills/abilities

1. Educational background and professional expertise

• Bachelors degree or above in food science Pharmacy bioengineering or related fields.
• More than 5 years of quality management experience in the health supplement pharmaceutical or plant extract industry familiar with domestic and international health supplement regulations (such as FDA cGMP Chinese health food regulations etc.).

2. Professional skills

• Proficient in GMP ISO9001 ISO22000 HACCP EHS and other management systems with experience in system construction and internal audits.
• Familiar with the production process quality control and OEM management of health care products and possess the ability to conduct third-party factory audits.
• Have experience in supporting new product R&D and be familiar with formula design process parameters and registration application procedures.

3. Language and communication skill

• Excellent written and oral communication skills in both Chinese and English (communication with global teams and suppliers is required).
• Outstanding cross-departmental coordination skills capable of efficiently connecting with production R&D registration and external partners.

4. Core qualities

• Strong analytical and problem-solving capabilities capable of leading deviation investigations CAPA (Corrective and Preventive Actions) and quality risk assessments.
• Strong sense of responsibility with a rigorous quality awareness and compliance thinking.
• Possess crisis management capabilities be able to formulate emergency response plans and promote drills.

Job content

Maintenance of the quality management system

• Coordinate the operation of GMP ISO and other systems organize internal audits external audits and management reviews to ensure compliance.

• Supervise the quality compliance throughout the entire process including supplier management raw and auxiliary material inspection production process control and finished product release.

2. Production quality supervision and improvement

• Monitor production deviations and the handling of non-conforming products and promote root cause analysis and improvement measures.
• Reduce the customer complaint rate lead complaint investigations and formulate prevention plans.

3. OEM factory management

• Screen and evaluate third-party contract manufacturers formulate annual audit plans and supervise the implementation of rectification measures.
• Ensure that third-party contract manufacturers continuously comply with the companys quality and regulatory standards.

4. Regulatory compliance and technical support

• Track the latest developments in domestic and international health product regulations assess their impacts and organize internal training.
• Provide regulatory support for the research and development of new products assist in the preparation of registration documents and trial production (small-scale trials/medium-scale trials).

5. Cross-departmental collaboration and crisis management

• Support the registration and R&D teams to ensure the feasibility of new product processes and compliance with market launch requirements.
• Establish a communication mechanism among government regulatory authorities to deal with flight inspections and compliance reviews.