北京招聘

Responsibility:

- Performs contracted, routine and complex internal audits according to client expectations and/or PRA SOPs. May function as a lead auditor on an audit team.

Plans and ensures audits are scheduled.

Conducts audits to identify non-conformities in adherence to protocols, SOPs, regulations, GCP, and expectations for data accuracy and completeness.

Reports non-conformities according to client or PRA SOPs and report templates.

Tracks, collects and reports responses and corrective actions per contract with client or PRA SOPs.

Documents closure of audits.

- Interprets regulations and guidance documents governing GxP and applies the interpretation for the PRAHS staff. Researches the published information, interacts with other QA/regulatory professionals and maintains knowledge of current expectations and new trends and proposed changes to regulations.

Shares questions and issues posed to QA with global PRA QA staff as necessary to insure best advice is obtained. Compiles response from QA staff and literature and replies to customer and more broadly throughout PRA as needed.

- Facilitates client audits and regulatory inspections of PRA to ensure that client auditors and inspectors receive access to needed documentation and staff with minimal disruption of ongoing operations.

- May be assigned to participate in QA projects such as management of issue escalations, CAPA projects, or other QA initiatives with supervision.

Requirement:

- An undergraduate degree, its international equivalent in health sciences, pharmacy, laboratory, clinical research, and/or auditing, etc. from an accredited institution or sufficient previous experience in auditing is required

- Read, write and speak fluent English; fluent in host country language required.

- 2+ years experience working the clinical, regulatory, or quality environment within CRO/ pharmaceutical / healthcare environment.

- Excellent verbal and written communication skills, interpersonal skills.

- Excellent organizational skills. Must possess a technical knowledge that is applicable to clinical drug development and possess the expected ability to master the needed understanding of clinical and technical areas

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.