QSR Specialist

Job description

JOB DESCRIPTION:

MAIN PURPOSE OF ROLE

·  Supporting external audit processes and the internal audit activities.
·  Supporting the compliance gap management activities including regulatory /standards tracking and other compliance management activities.

MAIN RESPONSIBILITIES

·  Support assigned internal/clinical audits to maintain timely closure of the audit cycles. May lead the assigned audits.
·  Support Audit Readiness activities for external audits including training staff /guidance in preparation of external audits
·  Support compliance gap management activities e.g. compliance risk management- Identifies risks to the division and resolutions to address compliance gaps.
·  Help management of near miss program
·  Prepares the metrics data
·  Promotes awareness and understanding of quality & compliance within the division.
·  Provide training to the division to increase the compliance awareness
·  Participate the compliance initiatives and other assigned projects

QUALIFICATIONS

·  Bachelors Degree or an equivalent combination of education and work experience
·  Minimum 3 years in Quality Assurance, Internal Auditing, Quality Compliance Management or related experience
·  Minimum 5 years in Medical Device /Pharma

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

        

LOCATION:

China > Hangzhou : #198 12th Street, Hangzhou Economic & Technological Development Area

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable