Healthcare Quality & Regulatory Compliance Specialist-Base or Senior

Description

1. Regulatory & Quality Compliance
•     Ensure compliance with Korean healthcare/pharmaceutical regulations (e.g., KGSP)
•     Approve incoming/released/returned products through specification and visual checks
•     Maintain and update key quality documents (Quality Manual, SOP, WI)
•     Conduct internal audits and oversee environmental hygiene
•     Interpret regulatory standards and ensure process compliance
•    한국 보건의료 및 의약품 규제(KGSP 등)에 따라 회사 규정 준수 여부를 관리하고 개선점을 도출
•    입고·출고·반품 제품에 대해 규격 및 외관 검수를 수행하고 승인
•    Quality Manual, SOP(Standard Operating Procedure), WI(Work Instruction) 등 핵심 품질 문서를 최신 규제 및 내부 프로세스에 맞게 유지·관리·개정함.
•    정기·수시 내부 감사(Internal Audit)를 수행하고, 환경위생 관리 상태를 점검하여 품질 리스크를 사전에 차단
•    관련 규제 및 가이드라인을 해석하고, 현장 운영 프로세스가 법적 요구사항 및 사내 품질 기준에 부합하도록 관리

2. Training Management
•     Develop and deliver regulatory/quality training programs for employees
•     규제, 품질(Quality) 관련 사내 교육 프로그램을 기획·개발

3. Quality Issue Management
•     Report and manage suspected counterfeit or adulterated products
•     Investigate and improve QMS issues (Change Control, Deviation, CAPA)
•     Record and monitor quality issues to prevent recurrence
•    위조 의약품, 변질 의심 제품 등 품질 이상 사례 발생 시 즉시 보고 및 관리
•    품질경영시스템(QMS) 내 Change Control, Deviation, CAPA 등 품질 문제를 조사·분석하고 개선 조치를 수립·추진
•    품질 이슈 관련 기록을 체계적으로 관리하고, 분석 결과를 기반으로 재발 방지 대책을 수립하여 품질 수준을 향상

FedEx was built on a philosophy that puts people first, one we take seriously. We are an equal opportunity/affirmative action employer and we are committed to a diverse, equitable, and inclusive workforce in which we enforce fair treatment, and provide growth opportunities for everyone.

All qualified applicants will receive consideration for employment regardless of age, race, color, national origin, genetics, religion, gender, marital status, pregnancy (including childbirth or a related medical condition), physical or mental disability, or any other characteristic protected by applicable laws, regulations, and ordinances.

Our Company

FedEx is one of the world's largest express transportation companies and has consistently been selected as one of the top 10 World’s Most Admired Companies by "Fortune" magazine. Every day FedEx delivers for its customers with transportation and business solutions, serving more than 220 countries and territories around the globe. We can serve this global network due to our outstanding team of FedEx team members, who are tasked with making every FedEx experience outstanding.

Our Philosophy

The People-Service-Profit philosophy (P-S-P) describes the principles that govern every FedEx decision, policy, or activity. FedEx takes care of our people; they, in turn, deliver the impeccable service demanded by our customers, who reward us with the profitability necessary to secure our future. The essential element in making the People-Service-Profit philosophy such a positive force for the company is where we close the circle, and return these profits back into the business, and invest back in our people. Our success in the industry is attributed to our people. Through our P-S-P philosophy, we have a work environment that encourages team members to be innovative in delivering the highest possible quality of service to our customers. We care for their well-being, and value their contributions to the company.

Our Culture

Our culture is important for many reasons, and we intentionally bring it to life through our behaviors, actions, and activities in every part of the world. The FedEx culture and values have been a cornerstone of our success and growth since we began in the early 1970’s. While other companies can copy our systems, infrastructure, and processes, our culture makes us unique and is often a differentiating factor as we compete and grow in today’s global marketplace.