4 дня назад
Quality Associate (Pharmaceutical Quality)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Associate (Pharmaceutical Quality): Managing product complaints, quality events, analytical method validation, quality documentation, product release, and GMP inspection activities with an accent on GxP systems, regulatory compliance, and cross-functional coordination. Focus on investigating deviations and CAPAs, maintaining quality agreements, supporting audits and inspections, and ensuring timely closure of quality actions.
Location: Seoul, South Korea
Employment: Full time; temporary position for 1.5 years
Company
An R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines based on deep expertise in the immune system.
What you will do
- Manage product technical complaints, quality events, deviations, change controls, and CAPA activities.
- Coordinate analytical method validation and transfer activities.
- Maintain quality agreements with manufacturing sites and third-party suppliers.
- Support product release activities in line with local regulatory requirements and quality standards.
- Maintain quality documentation, training records, and GxP-related training activities.
- Support audits and inspections, follow up on observations and CAPAs, and liaise with local health authorities.
Requirements
- 2–5 years of relevant experience in pharmaceutical quality assurance, quality control, or regulatory affairs.
- Degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Familiarity with GxP quality systems and complaint and deviation handling processes.
- Strong attention to detail, analytical thinking, and the ability to work independently and across cross-functional teams.
- Professional proficiency in English for collaboration with global teams.
Culture & Benefits
- Work on medicines and vaccines addressing chronic and complex conditions.
- Contribute to products reaching more than 100 million people each year.
- Operate in a digital- and AI-powered business environment.
- Access development opportunities across functions, regions, and the product lifecycle.
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