天津招聘

Responsibilities/Duties:

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 all projects have an Audit Plan written and that QA&C staffs are assigned to complete the required audits.

Assure that audits as defined in the project Audit Plan are completed on time and within budget.

Provide local leadership and line management as required.?

Act as a Lead Auditor.

Participate in audits, as assigned, according to applicable SOP(s) and the project Quality Plan

Provide guidance to QA&C project auditors regarding GCP issues relating to the project Quality 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 and action plans provided by auditees.

Prepare overviews of audit findings for presentation to management.

Serve as a backup auditor to other QA&C staff.

Support QA initiatives associated with tracking, trending and analysis of audit findings.

Contribute to process improvement initiatives across organization.

Develop and maintain global quality system to recognized standards.

Direct and/or participate in development of QA processes and SOPs.

Support development of processes and SOPs by process owners outside QA.

Represent QA at client meetings and/or audits


Education/Qualifications

Bachelor's degree required; Master's degree preferred

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

Experience Minimum of five years experience in the pharmaceutical/CRO industries, with three years in Clinical Quality Assurance, preferably within a GCP environment

Strong analytical skills

Excellent technical knowledge, understanding and experience applying ICH/FDA Good Clinical Practices

Excellent oral, written and presentation skills

Excellent planning and organizational skills

Proven interpersonal skills

Demonstrated ability to handle multiple competing priorities across clinical operating units

Ability to inspire effective teamwork and motivate staff within a matrix system

Ability to function as a member of a global clinical team

This position requires travel up to 30% of the time.

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/