上海招聘

职位描述：
1. Plan, prepare and conduct trial specific, quality system, and vendor
qualification audits and report findings to the auditees.
2. Create QA SOPs required for the proper functioning of the clinical trial process.
3. Act as Quality Project Lead (QPL) on assigned studies, ensuring quality related
oversight of projects and to act as a QA point of contact for study team
members.
4. Audit the quality of the clinical trial against the defined project-specific quality
and performance standards as well as relevant SOPs, ICH/GCP, and localrequirements; prepare audit reports within a timely manner; identify any failure to meet the standards and address the issue immediately with the Project Manager; and if required, with Chiltern Senior Management.
5. Provide regular feedback to the QA Audit Management team about the quality standards practiced in the company and give recommendations for their improvement.
6. Provide support and advice to other departments for quality improvement.
7. Conduct project specific, internal system audits and vendor audits to assess the quality standards and provide recommendations; prepare audit reports within a timely manner.
8. Provide GCP/GMP consultancy and advice in response to questions raised by individuals from the organization.
9. Actively participate in training sessions and workshops, including presenting reports from any conferences attended.
10. Ensure timely completion and documentation of all training requirements.
11. Ensure that systems and processes agreed and implemented by management will ensure that Clinical Trials have been performed, and data is generated, in compliance with ICH-GCP and other applicable regulations.
12. Be aware of updates to regulations, guidelines and principles related to Good Clinical Practice (GCP) and advise on their use and compliance.
13. Other duties, as required by the Quality Assurance department. 举报 分享

Chiltern is a leading CRO that listens to client needs in order to customize solutions for the Biopharma industry. With a 32 year history, Chiltern delivers globally with therapeutic expertise in oncology, respiratory, anti-infectives / vaccines, ophthalmology and dermatology. Chiltern operates two specialty units: Chiltern Oncology is led by physicians, scientists and clinicians to uniquely manage all phases of hematologic and oncologic clinical drug development; and Chiltern Source is a world leader in tailored relationships for FSP, resourcing and staffing solutions. Chiltern’s 2,200 engaged professionals work across 45 countries to deliver flexible, responsive solutions that are “Designed Around You”.