Job Description
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.
The Position
Affiliate: Roche Pharma Korea
Cluster: Access & Policy
Work Location: Hanam City, Gyeonggi-do
Worker Type: Regular
Your key responsibilities
Advanced QC Testing: Perform QC testing for biological/chemical drug products utilizing various compendial and in-house validated methods (e.g., ID/Purity by CE, HPLC & UPLC, Content by UV/Vis, Cell-based Assays), ensuring strict adherence to SOPs and test protocols.
QC Material & Cell Bank Management: Manage and maintain critical QC materials including QC/retention samples, critical reagents, and cell banking.
Method Transfer (SME): Lead or support internal/external analytical method transfer activities, providing technical expertise on key analytical methods as a Subject Matter Expert.
Investigation & Quality Management: Handling of deviations, OOS/OOT investigations, change controls, CAPA, and risk assessments, identifying root causes and implementing effective actions.
Audit & QMR Leadership: Act as an internal or external GxP auditor/co-auditor and represent the QC function as a member of the local QMR (Quality Management Review) Meeting.
Data Integrity & Review: Conduct technical review of QC raw data and analytical results, adhering strictly to the current GxP good documentation practices and data integrity requirements.
Equipment Lifecycle Management: Execute and coordinate qualification, calibration, and preventive maintenance of QC equipment ensuring intended use.
Documentation & Regulatory Collaboration: Draft, review, and revise various QC SOPs, work instructions, protocols, and reports. Collaborate closely with RA for the preparation of specifications and test methods for drug product registration.
Who you are
Basic qualification: Bachelor of Science majoring in biotechnology or related science.
A minimum of 4 years experience in developing and executing quality control operation, and laboratory experience in pharmaceutical company.
A strong background and in-depth knowledge in Instrumental analysis (HPLC, UV, CE, Spectrophotometer, Plate Reader, etc.) and cell-based assays.
Good English written and communication skill.
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 서류전형 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.
Who we are
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.