JOB DESCRIPTION:

Core Job Responsibilities:

• Manage on-site audits for supplier and Third-party Manufacturers that provide materials/services to EPD..
• All activities required to plan, prepare for, conduct, report and close the assigned audits.
• Ensure that all audit related information is documented into the Audit Tracking system in a timely manner.
• Manage Quality Questionnaire for supplies and Third-Party Manufacturers
• Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA follow-up to close for supplier and TPMs evaluated.
• Timely information on the audits to management and stakeholders. Escalation of any critical findings or negative audit outcomes to EPD Auditing management, in line with the applicable policy and procedures.
• Reviewing any Quality Questionnaires returned by the Suppliers/TPMs and resolve any issues.
• Read and extract developing regulations and trends from available sources to provide recent perspectives during audits.
• Ensure a proactive determination of regulatory, compliance and quality issues and integrate them into audits/assessments on a priority basis.
• Provide support to EPD plants in the timely resolution of issues related to suppliers.  Discuss with and agree with the supplier a timely implementation of corrective and preventive actions, as needed to prevent recurrence

Minimum Education:

• Bachelor’s degree or equivalent level of education at a relevant scientific discipline (Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific), or industry experience with sufficient exposure to pharmaceutical or related industries.

Minimum Experience/Training Required:

• At least 8 years in the Pharmaceutical/Healthcare Industry and/or Government Regulatory Agency; and at least 3 years of Auditing experience related to GMP, GDP or ISO for Pharma, Medical Devices and Nutritional product types
• Knowledge and understanding of the ICH and other relevant technical guidelines, as well as GMP guidelines.
• Understanding of the WHO and other applicable regional and local regulations
• Good Communication skills
• Advanced written and verbal skills in Business English
• Competencies required: adaptability, initiative, integrity, planning & organizing, information gathering, analytical thinking, interpersonal understanding, cultural sensitivity, ethical behavior, independence, decisiveness
• Availability for traveling.

The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

EPD Established Pharma:

LOCATION:

China > Shanghai : 388 W. Nanjing Road, Ciros Plaza

ADDITIONAL LOCATIONS: ##WORK SHIFT:
Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable