The Position

Affiliate: Roche Pharma Korera

Open Position Title: QC Partner
Cluster: Access & Policy
Work Location: Gyeonggi-do Hanam City

Your Key Responsibilities

• QC testing for biological/chemical drug products (ID/Purity by CE, HPLC & UPLC, Content by UV/Vis, Cell based Assays, etc.)
• Management of QC equipment qualification, calibration, and preventive maintenance
• Both internal and external analytical method transfer exercise as a SME
• Technical review of QC raw data
• Internal or external GxP auditor/co-auditor
• Various QC SOPs, work instructions, protocols, and report generation/revision (as necessary)
• Handling of deviation, OOS investigation, change control, CAPA, and risk assessment, etc.
• Adhere to the current GxP good documentation practices and data integrity requirements
• Management of QC material: QC sample/Retention sample, critical reagents, & cell banking
• A member of local QMR Meeting (Quality Management Review Meeting)
• Collaboration work with RA: Preparation of specification and test method for drug product

Requirements

• Minimum Bachelor’s degree in Biochemistry, Bioengineering, Chemistry, and/or relevant background
• Minimum 3 - 10 years’ experience in Pharmaceutical industry
• A strong background and in depth knowledge of instrumental analysis (UV Spectrophotometer, HPLC, CE, etc.) is preferable.
• A good understanding of local GxP regulations, QA & QC, Regulatory Compliance, etc.
• Fluent in English both oral and written

Submission

• English and Korean resume and self-introduction in 1 MS Word file or PDF file.
• Please include your current salary and expected salary information in your resume.
• 국, 영문 이력서와 국, 영문 자기소개서를 1개의 MS Word 혹은 PDF 파일로 제출
• 이력서 상단에 현재 연봉과 희망 연봉을 반드시 표기하시기 바랍니다. 누락시 이력서가 검토되지 않습니다.

Next Step

1. Job application screening 서류 전형

2. Interview 면접 전형

- Interview will be informed to the candidate who passes the resume screen test.

- 면접은 서류전형 합격자에 한해 개별 통보합니다.

- 실무진 면접, 임원 면접

3. Overall assessment 종합 심사

4. Final notification via job offer letter 최종 합격 통지

* The finalist is selected after the comprehensive assessment which includes candidates’ reference check, background check on employment history, education, etc and medical check-up.

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

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.