Quality Auditor
Share
Job Location:
Monthly Salary:
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
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:
- Bachelors 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
Required Experience:
IC
Key Skills
- Quality Assurance
- Quality Inspection
- Calipers
- ISO 9001
- Quality Audits
- Process Mapping
- Fair Housing Regulations
- Quality Control
- Underwriting
- cGMP
- As9100
- Manufacturing
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
