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 ManufacturersAssess 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 typesKnowledge 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 regulationsGood Communication skillsAdvanced written and verbal skills in Business EnglishCompetencies required: adaptability, initiative, integrity, planning & organizing, information gathering, analytical thinking, interpersonal understanding, cultural sensitivity, ethical behavior, independence, decisivenessAvailability for traveling.