6 дней назад
Spec, Quality Assurance (Pharmaceuticals and Medical Devices)
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
Spec, Quality Assurance (Pharmaceuticals and Medical Devices): Managing quality assurance and regulatory compliance for pharmaceutical and medical device operations in Korea with an accent on product release, field actions, complaints, quality documentation, and GMP requirements. Focus on coordinating MFDS reporting, maintaining licenses and certifications, supporting audits, and improving quality systems across internal and external partners.
Location: Seoul, South Korea; onsite
Company
Vital organ therapy company developing pharmaceutical, medical device, digital, and advanced care solutions, with a long-standing focus on kidney care.
What you will do
- Manage product release, labeling, product holds, and local testing activities for pharmaceuticals and medical devices.
- Lead analytical method transfers, field actions, complaint handling, vigilance activities, and adverse-event reporting to the MFDS.
- Maintain local quality documents, including SOPs, manuals, APQRs, product master files, licenses, and KGMP certifications.
- Perform QMS, change control, training compliance, audit support, and quality improvement activities.
- Support GMP and Good Warehousing Practices across warehousing operations and third-party providers.
- Collaborate with Regulatory Affairs, Business Units, Fulfillment, Planning, distributors, contractors, and other stakeholders.
Requirements
- Korean pharmacist license required.
- 3–7 years of Quality Assurance experience in the healthcare industry, including essential pharmaceutical industry experience.
- Knowledge of GMP and Korean pharmaceutical and medical device regulations.
- Strong written and verbal communication skills in both Korean and English.
- Confidence in presenting viewpoints, listening to differing opinions, and adapting communication to different audiences.
Culture & Benefits
- Mission-driven work focused on extending lives and expanding possibilities for patients and care teams.
- Collaboration across quality, regulatory, commercial, fulfillment, planning, and external partner functions.
- Reasonable accommodations are available during the application and interview process for candidates with disabilities or medical conditions.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →