北京招聘

Job Title: Quality Auditor

Department Name: Global Quality Assurance

Location: Shanghai, China

Reports to Title: Singapore and Asia Pacific Regional Manager Quality, CCLS



I. Job Summary:



1) Experience and knowledgeable in auditing techniques, regulatory requirements, process improvement and problem solving skills to audit the company for regulatory compliance.

2) Be customer service focused and exhibit exemplary customer service skills, potential direct customer involvement during audits and problem resolution.

3) Exhibits attention to detail, is organized, and demonstrates strong written and verbal communication skills, including public speaking.

4) Be team-oriented providing support and expertise in achieving regulatory compliance and customer satisfaction by educating, analyzing and facilitating improvements.



A. Duties and Responsibilities:

i. Essential Functions

1. To ensure that appropriate quality-based audits are prepared, conducted and closed in an efficient, effective, and timely manner. Quality-based audits include: Internal Audits, Facility Audits, Raw Data Audits, Quality System Audits, Product Audits, etc.

2. Identify communicate and act upon opportunities for process improvement based on audit or inspection observations.

3. Provide updates on regulatory changes to departments within company as needed.

4. Conduct quality training for internal customers providing applicable regulatory focus.

5. Lead, organize and participant in the client audit process.

6. Accept assignments to research internal issues, following the issue to resolution meeting regulatory compliance.

7. Participate in communication with the CCLS quality group and other Covance businesses to promote consistency and identify best practices.

8. Coordinate and promote global processes where possible.

9. Complete other projects as assigned.



ii. Additional Functions

1. Follows through on requests, needs, and messages in a timely manner

2. Timely completion of monthly status reports.

3. Communicated, promotes, administers, and follows company policies on a consistent basis.

4. Keeps current in all requirements for position, including but not limited to: training files, continuing education, seminars, and training sessions.

5. Complies with Covance Quality System initiatives and actively demonstrates the Covance Way.

6. Ensures effective communication.

a. Establishes communications with customers to ensure customer satisfaction and retention.

b. Relates service failures to appropriate internal Covance personnel.

c. Proactively manages and drive resolution of customer issues within and across all departments and locations of Covance.

7. Performs other related duties as assigned.



Up to 30% of the time to both domestic and international travel required – including overnight stays



II. Experience:



Required:

o Bachelor’s Degree or equivalent with 1 – 3 Years quality related experience, or an Associate’s degree or equivalent with 3 – 5 years quality related experience. Preferences are that the experiences are within a regulated environment, prioritized as follows: 1) Pharmaceutical/Laboratory, 2) Food/Nutrition, and 3) Information Technology.

o Must have exemplary customer service skills exhibited in internal and external audits.

o Must be proficient in the use of desktop computer applications, including Microsoft Office applications.

o Ability to apply analytical and systematic thinking, using data and facts to identify, communicate and act upon (and get others to act upon) opportunities to continuously improve performance.

o Ability to manage difficult client conversations in a constructive non confrontational manner

o Ability to lead programs, processes and teams, establishing clear expectations and accountabilities.



Preferred:

o Formal GCP, GLP training and Degree within the Life Sciences

o Supported an accreditation or certification process


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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.

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