7 дней назад
MS Quality Control Analyst IFB (Pharmaceutical)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
MS Quality Control Analyst IFB (Pharmaceutical): Establishing and operating a quality control laboratory for insulin drug substance manufacturing with an accent on chemical, physicochemical, and bioanalytical testing. Focus on analytical method transfers and validation, data review, equipment qualification, GMP documentation, and troubleshooting quality control issues.
Location: Beijing, China; onsite
Company
develops medicines and conducts pharmaceutical research focused on improving health outcomes.
What you will do
- Participate in establishing, qualifying, and commissioning the IFB quality control laboratory.
- Perform chemical, physicochemical, bioanalytical, wet chemistry, and instrumental testing for insulin drug substance release, incoming materials, in-process controls, clean utilities, and cleaning validation.
- Support analytical method transfers, verification, validation, equipment qualification, calibration, and maintenance.
- Review analytical data produced by other analysts and complete testing according to scheduled plans.
- Prepare and maintain laboratory specifications, methods, procedures, protocols, reports, SOPs, logbooks, raw data, and calculations.
- Investigate analytical issues, manage reagents and reference standards, and execute CAPAs and continuous improvement activities.
Requirements
- Degree in chemistry, pharmacy, biochemistry, or an equivalent field; an associate degree is the minimum, with a bachelor’s degree or higher preferred.
- At least two years of experience in the pharmaceutical, food, or biotechnology industry.
- Quality control experience in the pharmaceutical industry with knowledge of GMP and regulatory requirements.
- Professional experience with HPLC, GC, UV, IR, titration, TOC, and wet chemistry analysis.
- Ability to analyze complex laboratory data, identify quality issues, and implement effective solutions.
- Familiarity with academic English, German, and Mandarin across at least two modalities, including reading and writing.
Nice to have
- Experience with in-process control analysis of active ingredients.
- Experience with equipment qualification or analytical method validation, verification, or transfer.
Culture & Benefits
- Work in accordance with cGMP, HSE, data integrity, and laboratory quality requirements.
- Collaborate on remediation plans and continuous improvement initiatives.
- Operate within an equal-opportunity and inclusive working environment.
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