上海招聘

Overview

Responsible for enforcing an efficient and compliant auditing program according to senior management-approved Quality Assurance Operating Plan and company SOPs (Standard Operating Procedures), GxP (e.g. GCP, GLP, GMP, GPvP, GDP, etc.) and clinical trials regulations. Provides expertise on the design, implementation and development of GxP, systems, processes and procedures.
May manage QA auditors’ team to ensure contracted and internal audits are performed, findings reported to management and/or clients, and corrective actions evaluated.
May have responsibility to support specific operations such as:

• Clinical Pharmacology Unit
• Bioanalytical Laboratory
• Logistics
• GMP Pharmacy
• Computerised Systems

Responsibilities

• Participates in the selection, hiring and training of new QA staff.
• May functionally manage 1-15 Auditors and/or manage other managers
• Leads QA auditors' team by providing clear team / individual goals and expectations and ensuring that each member of the auditing staff understands her/his responsibility to know and follow all SOPs and corporate policies
• Contributes to the development and ensures implementation of the Quality Assurance operating plan
• Makes recommendations for and assist in the development of Quality Assurance policies, procedures and practices. Maintains awareness of new system implementations, Quality Assurance and technological advancements.

Qualifications

• 7+ years experience with auditing, compliance, and SOP development required, 2 years experience direct management of staff.
• Compliance or auditing management experience required.
• Must have thorough understanding of GCP and EC and/or US regulations
• Understanding of all aspects of clinical research, including protocol development, CRF design, clinical trial management (including laboratory methodologies ad clinical examinations), data management, statistical analysis, clinical study reports, and regulatory submissions preferred
• Read, write and speak fluent English;fluent in host country language required. Fluency in other languages is a plus.

RPS Inc. is a next generation global CRO, headquartered in the United States with the operations in 45 countries throughout Americas (US, Canada, Latin America), EMEA and Asia Pacific regions. RPS provides comprehensive global Phase 1-4 clinical development solutions to the pharmaceutical, biotechnology and medical device industries. By combining an experienced clinical research operations infrastructure with the industry’s largest resourcing engines, RPS is uniquely positioned to offer our Clients both integrated and full service global outsourcing solutions. These solutions are powered by highly experienced and seasoned study teams providing innovative, cost-effective and high quality services.


RPS Asia Pacific Headquarters is located in Beijing, China and we have operations in 11 Countries in Asia Pacific region. With the rapid organic expansion of RPS in China & Asia Pacific, we are continuously looking for the experienced industry talents to join us.


Our specialized staff of consultants is eager to discuss your career plans. Tell us about yourself experience, so the appropriate consultant can contact you. RPS is sensitive to your daily responsibilities. Tell us EXACTLY how to contact you and we will. For your convenience, you can also submit your resume. We look forward to discussing the opportunities and benefits of employment with RPS!


For more information, please visit our website www.rpsweb.com.