QC Partner(Contractor) at F. Hoffmann-La Roche Ltd - Poland

Seoul, Gyeonggi-do, South Korea -

Full Time

Start Date

Immediate

Expiry Date

17 Jun, 26

Salary

0.0

Posted On

19 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Qc Operations, Testing, Biological Drug Products, Chemical Drug Products, Sops, Equipment Lifecycle Management, Qualification, Calibration, Preventive Maintenance, Hplc, Ce, Data Integrity, Audit Trails, Alcoa+, Method Transfer, Investigation

Industry

Biotechnology Research

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: 1.5 year contractor - Your key responsibilities QC Operations & Testing: Perform QC testing for biological/chemical drug products utilizing compendial methods, ensuring strict adherence to SOPs and test protocols. Equipment Lifecycle Management: Execute and coordinate qualification, calibration, and preventive maintenance of QC instruments (HPLC, CE, etc.) ensuring intended use. Data Integrity & Review: Conduct technical review of analytical data (including Audit Trails) to verify compliance with ALCOA+ principles. Method Transfer: Support internal/external analytical method transfer activities, providing technical expertise on key analytical methods. Investigation & CAPA: Lead or support investigations for OOS/OOT results and deviations, identifying root causes and implementing effective CAPAs. Documentation: Draft and revise QC SOPs, protocols, and reports, ensuring Good Documentation Practices (GDP) are maintained. Regulatory Collaboration: Collaborate with RA to establish 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 3 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.). 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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

The role involves performing QC testing for biological/chemical drug products using compendial methods, managing the lifecycle of QC instruments through qualification and maintenance, and conducting technical reviews of analytical data for compliance.