Associate QA Manager (M&S) / QA Manager (M&S))

Job Description:

Main Accountabilities：

General:

1. As back up of China Quality Responsible Person, support to establish, maintain and continually improve the commercial quality system and ensure its effective operation. Ensure the commercial quality system and daily quality management activities complying with applicable regulations, GxP requirements and Ferring Global Procedures.

2. Monitor new regulations and perform impact assessment.

3. Organize the meeting of quality review

4. Quality Performance Indicator monitoring and improving

Detailed breakdown:

Documentation management system:

1. Acting as the Document Responsible Person, establish, maintain and continually improve documentation management system to comply with applicable regulations, GxP requirements and Ferring Global Procedures.

2. Create or review all commercial GxP documents.

3. Acting as Document Controller, know well the operations of e-system, providing support to staff who use e-system.

Complaint management:

1. Acting as local complaint coordinator, ensure timely recording and reporting of complaint in e-system

2. Monitor complaint progress and close the complaint Follow up the implementation of CAPA. Trend monitoring and take actions where appropriate.

Deviation and transport deviation management:

1. Discover deviation and register in e-system

2. Follow up the deviation investigation until its appropriate closure Follow up the implementation of CAPA. Trend monitoring and take actions where appropriate.

Inspection and audit:

1. Lead the preparation for official/GQA audit to ensure inspection readiness, prepare the response to address the observations and follow up. 2. Maintain self-inspection system and implement, follow up the CAPA of findings.

Supplier and customer management:

1. Maintain and improve the supplier and customer management. Identify the supplier and customer, qualify them following SOPs.

2. Prepare and sign the quality agreement with supplier and customer. Training:

1. Provide orientation quality training and filed training to sales force

2. Key users of e-system, create training material and assign training. follow up the completion of training.

Change control:

1. Discover change and register in e-system

2. Change evaluation and approval, follow up the completion of action plan. DRP of MAH:

1. Assume responsibility of MAH, undertake the joint liability together with MAH, e.g. annual report

2. Maintain the quality system to meet MAH deputy requirements.

3. Keep close contact with authority and host the routine inspection

Recall:

1. Acting as Back up of Local Recall Responsible Person, support Critical Situation assessment and in close collaboration with Global/Hub

2. Manage local recall execution - communication with local competent authorities, return handling and reconciliation

3. Maintain mock recall system and execute mock recall

Behind our talent, there is You

Knowledge (education, qualification and training)

• Mandatory-licensed pharmacist
• Has attended external courses of auditor; Can perform quality audit to partner independently is preferred.
• Bachelor or above, in pharmacy or related field;
• Familiar with GxP regulations
• Be able to communicate in English

Skills

• Good communication and collaboration skills
• Ideal leadership and result oriented
• Handling complexity, problem solving, analytical and conceptual skills

Experience

• Over 5-years experience in pharmaceutical company

Sufficient experience in driving compliance such as GMP, GDP.

Project/BD deal/QA initiative

1. Resolve Quality issues arising from Project/BD deal/QA initiative.

2. Support and collaborate on projects/BD deals/QA initiatives, provide professional QA comments and solutions, with balance on business needs Planning annual budget and cost control of commercial QA operation

Location: