天津招聘

Responsibility:
? Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines, and fulfill client and Covance requirements.
? Assure that audits assigned are completed on time and within budget, including audit reporting and CAPA follow up and closure.
? Auditing
- act as a Lead Auditor
- participate in audits, as assigned, according to applicable SOP(s) and the global audit plan
- identify non-conformances with requirements and provide suitable recommendations
- assure that audit reports are completed in a timely manner and that audit results are communicated to auditees and management
- ensure suitable responses to CAPAs are provided by auditees within the agreed timeframe
- escalate to QA management where resolution of audit findings are inadequate
- follow up and closure of audits and CAPAs within agreed timeframe
- maintain all audit and CAPA tracking systems
- serve as a backup auditor to other QA&C staff
? Special Projects
- participate in QA projects
- support special projects requiring QA input
? Quality Assurance
- act as Global QA Lead or Backup on assigned projects, providing GxP advice and QA oversight for project teams
- contribute to process improvement initiatives across organization
- provide support to maintain global quality system to recognized standards
- participate in development of QA processes and SOPs
- support development of processes and SOPs by process owners outside QA
? Liaison / Representation
- represent QA on project teams, and other internal forums
- represent QA at client meetings and/or audits
Approximately 25-50% travel with primary scope limited to Latin America.

Requirement:
2 Years of experience in Clinical Quality Assurance, preferably with GCP experience.
3 Years of experience in other professional roles within pharmaceutical/CRO environment.
Other required work-related experiences:
? Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
? Financial understanding of global clinical development budgets
? Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
? Knowledge of the drug development process from the perspective of a contract research organization.

You can refer and submit CV by system or email to calvin.xu@covance.com

You are strongly encouraged to visit our recruitment website as http://careers.covance.cn/

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

Well come to our online job pool to dig out more opportunities at:
http://careers.covance.cn/