At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

Cluster : Access and Policy

Job title : QA Partner

Work location: Seoul

Main Responsibilities

Management of Product Quality Assurance, Quality System, Regulatory Compliance, Artworks and Quality Issues
 

1. Management of product release, artwork, complaint and APQR

Prepare the product release after reviewing and preparing the relevant documents within defined timeframe

Ensure all the product release complies with Korean regulation & global SOPs

Manage and prepare Artwork without any regulatory incompliance and monitor the process according to the defined schedule.

Prepare the packaging materials and review the batch record for redressing activity

Communicate with Global Artwork coordinator and timely shares information with relevant department for the artwork implementation in a timely manner

Product complaint handling in line with Global complaint management in a timely manner

Perform Annual Product Quality Review to evaluate the product quality and quality system of Roche Korea

2. Management and maintenance of quality system

Ensure that all the global SOPs & local regulations are implemented in all the relevant operating guidelines & SOPs

Deliver the right GxP training in a timely manner and ensure that planned tranings are implemented and personnel qualifications are suitable for the respective operation.

Lead Change Management, Deviation Management, CAPA procedure, Risk Management and Validation & Qualification as described in SOPs

Support and conduct the 3rd party audit as well as Internal audit as the auditor or SME Management of outsourced operation and quality agreement

Management and support of quality issue (e.g. recall) and field actions 

Requirements

Bachelor degree or equivalent (majored in Pharmacy preferred)

Minimum 3 years of work experience in pharmaceutical quality field

Knowledge of Pharmaceutical Affairs law and GxP regulation

Demonstrated excellence in documentation

Experiences of SAP, e- global quality management system (e.g. Veeva) preferred

Good at communication and computer skill

Good Korean and English proficiency

Submission

자유 양식의 국/영문 이력서 및 국/영문 자기소개서 (하나의 MS Word 혹은 PDF 파일로 제출)

※ 이력서 상단에 반드시 현재 연봉과 희망 연봉을 표기하시기 바랍니다. 누락 시 이력서가 검토되지 않습니다.

※ 이력서 내 이메일 주소와 서류 전형 지원 사이트의 입력하시는 이메일 주소를 반드시 동일하게 작성해주시기 바랍니다. 

※ 국가보훈대상 및 장애인은 관련 서류 제출시 관련 법규에 의거 우대합니다.

※ 이력서에 개인민감정보 (신체적 조건, 출신 지역, 혼인 여부, 가족관계 등)는 기재하지 말아주십시오.

※ 입사 지원 서류에 허위 사실이 발견될 경우, 채용 확정 이후 라도 채용이 취소될 수 있습니다.
 

Process

서류 전형▶ 면접 전형 ▶ 종합 심사 ▶ 최종 합격 통지

※ 면접은 서류전형 합격자에 한해 개별 통보합니다.

※ 면접 일정 안내 및 조율을 위해 해외 번호(중국)로 연락이 갈 수 있는 점 미리 안내드립니다.

※채용이 유력한 후보자에 대해서 이력 검증 및 평판 조회, 건강검진 등의 종합심사를 진행하여 최종 합격자를 선정합니다.

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.