天津招聘

Accountability：

  

一、Establish quality assurance strategy as MAH or in-country caretaker

  

The following activities are conducted by Associate Manager with a support of a manager.

  

1. Establish product quality policy and management strategy with support of a manager to manage 3PLs and CMOs.

2. Perform market release judgement for finished goods importation model.

3. Prepare and maintain Quality Agreement with business partners.

4. Perform on-site quality audit for business partners and advise several solutions to improve their quality systems.

5. Establish regulatory intelligence in QA and keep department expertise about quality related regulations the best.

6. Support new product launch project from quality assurance point of view.

7. Appliy quality risk management to prioritize tasks and circulate improvement process.

    

                

二、Third-Party Management

  

The following activities are conducted by Associate Manager with a support of a manager.

  

1. Execute and maintain Quality Agreements with 3PLs.

2. Establish KPIs or other metrics to monitor 3PL’s performance and give proper advice to them.

3. Perform on-site quality audit for 3PLs and advise several solutions to improve their quality systems.

4. Organize periodical meeting with 3PLs to discuss quality assurance and regulatory compliance.

5. Handle any deviation caused by 3PLs and evaluate impact on product quality.

6. Perform 3PL risk assessment annually and support enhancement of risk mitigation plans.

7. Conduct transportation lane risk assessment and mitigate the identified risks scientifically.

8. Review all quality-related incidents happened in a year and establish management strategy for next year.

    

                  

三、Wholesaler Quality Management

  

The following activities are conducted by Associate Manager with a support of a manager.

  

1. Perform wholesaler risk assessment and maintain qualified vendor list.

2. Execute and maintain Quality Agreements with wholesalers.

3. Perform on-site quality audit for wholesalers and advise several solutions to improve their quality systems.

4. Review all quality-related incidents happened in a year and establish management strategy for next year.

        

 

  

四、Quality Information Handling

  

The following activities are conducted by Associate Manager with a support of a manager.

  

1. Handle quality information from the market such as product quality complaints in collaboration with Shenyang plant and foreign manufacturers.

2. Handle product security incidents in collaboration with Shenyang plant and Global Product Security Team.

3. Support Call Center activity in terms of quality assurance.

      

 

  

五、Self-Inspection / Internal Audit / HA Inspection

  

The following activities are conducted by Associate Manager with a support of a manager.

  

1. Conduct quality system self-inspection annually and improve quality systems.

2. Take internal quality audit performed by global audit team and improve quality systems.

3. Facilitate Health Authority inspection in terms of quality assurance and complete CAPA.

    

        

六、Product Recall

  

The following activities are conducted by Associate Manager with a support of a manager.

  

1. Communicate global risk evaluation committee regarding significant quality issue happened in China Mainland territory to decide market action.

2. Fully organize product recall and prepare several reports to health authority.

3. Perform annual mock recall.

4. Conduct training to keep professionality about Chinese regulations related to product recall.

        

 

  

七、Other tasks under quality systems

  

The following activities are conducted by Associate Manager with a support of a manager.

  

1. Provide trainings about responsible operations and activities.

2. Manage art work in collaboration with Regulatory Affairs.

3. Maintain IT vendor list.

4. Perform change control (eg. GXP IT system change) to evaluate impact on product quality.

5. Make documentation of all responsible quality activities[LY艳1] .

          

 

  

八、Other tasks temporarily assigned by the line manager

  

According to the requirements of the line manager, complete the task on time

  

 

  

Qualifications：

  

1. Education

  

Bachelor degree or above in pharmacy and related majors.

  

二、Skills

  

1. Strong coordination and communication skills, analysis and problem-solving skills, planning and execution skills, and time management skills.

2. Growth mind set and logical thinking skills, able to enjoy challenges and new things.

3. Received training on GMP/GSP and other quality regulations and other relevant pharmaceutical administration regulations, and has extensive knowledge and experience in DAL (Drug Administration Law and its supportive regulations), GSP, GDP, GMP, ICH, ISO9001 and other quality systems;

4. Familiar with the quality management system and its working procedures;

5. Have certain knowledge of supply chain management and distribution, familiar with MS office system, warehouse management system;

6. Business level of English conversation skill

            

 

  

三、Experience

  

1. More than 5 years of working experience in pharmaceutical production or business enterprises;

2. At least 3 years of experience in quality management in pharmaceutical foreign companies or joint ventures

              

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