宁波招聘

Position: Quality Assurance Auditor

Report to: Head of Regional Quality Management

Department: QA

Base: Shanghai

Overview:

Within BI Medicine and QRPE, Asia, to maintain high quality standards and GCP compliance and to ensure regulatory requirements are met. Develop QA Audit Plan defining the QA audit activities to be performed and timelines for completion. Perform activities outlined in the activity plan and generate relevant reports and follow-up on CAPA.

Responsibilities

1. Audit Responsibilities

- Develop Local QA activity plan

- Plan and perform system, process and product audits in Asia as per audit plan

- Writes draft audit report with action plans, final audit report and the audit certificates for audits performed.

- Distribute audit reports and certificates as per BI SOPs/guidelines.

- Follow-up with auditees for Corrective Action Preventive Action (CAPA).

- Archives audit related documents in paper and electronically in Documentum.

- Maintain a log of QA audit activities.

- Report QA Activities on a quarterly basis.

2. General Responsibilities

- Identify training needs from audit experiences and provide feedback to trainer and Head of QM - M&R, Asia

- Provide QA/GCP guidance/support to clinical project teams and investigational site staff within Asia

- Provide support/guidance for Clinical Project Teams

- Provide support to Global QA and other OPUs as required

- Represent QA in appropriate and assigned task forces

- Represent Asia as member of QA auditor

- Act as liaison for regulatory inspections within the Asia region

Competencies

- Adheres to the Company's Code of Conduct, polices and procedures.

- Knowledgeable in Corporate BI Medical SOPs/Guidelines

- Knowledgeable in ICH-GCP guidelines and regulatory requirements/regulations of countries in Asia

- Knowledgeable in Safety Reporting guidelines and regulations of countries in Asia

- Takes responsibility for timely decisions and actions, taking prompt action to accomplish objectives/goals proactively.

- Able to work independently with minimal supervision

- Able to organize and prioritize work to achieve maximum productivity.

- Responsible to proactively seek and complete training on areas which are necessary to perform or enhance job function.

Pre-requisite:

- Life Sciences degree, preferably in medical, pharmaceutical, nursing, nutrition or other health related fields

- GCP practical experience ie worked as clinical monitor (CRA) or has experienced in managing international clinical trials (PM); minimum 2-3 years

- QA Audit experience; minimum 2 years with other clinical research experience

- Has regional (Asia) or international experience either as a QA Auditor or in clinical monitoring/project management

- Strong and effcetive communication skills both written and verbal (English)

- Advantage if able to speak and read other Asian languages (e.g. Mandarin, Korean)

- Able to travel extensively (50% - 70%) within the Asia region

- Re-locate-able to an Asian country, where needed

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