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6 дней назад

QA Manager (1 Year Contract) (Pharmaceutical Quality)

Формат работы
onsite
Тип работы
project
Грейд
senior
Английский
b2
Страна
SK
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
QA Manager (1 Year Contract) (Pharmaceutical Quality): Leading quality operations for pharmaceutical and medical device importation, testing, repackaging, storage, release, and distribution in Korea with an accent on Korean regulatory compliance, QMS management, and supplier oversight. Focus on maintaining GDP/GDPMD, cGMP, PIC/S, ICH, and ISO compliance, resolving deviations and CAPAs, and supporting audits, inspections, and product quality activities.

Location: Seoul, South Korea; onsite role. A certified pharmacist license in Korea is required.

Company

hirify.global is a Japan-originated life sciences company focused exclusively on ophthalmology, developing eye-care treatments and digital solutions across more than 60 countries.

What you will do

  • Manage quality operations covering importation, local testing, repackaging, storage, shipment, release, and distribution.
  • Support the implementation, maintenance, and continuous improvement of the local Quality Management System.
  • Coordinate quality activities with Supply Chain, Regulatory Affairs, Safety Vigilance, commercial teams, distributors, warehouses, laboratories, and service providers.
  • Oversee product receipt, warehousing checks, testing coordination, batch and shipment release, temperature excursions, deviations, and product quality issues.
  • Act as the responsible Pharmacist and Import Manager where required, ensuring appropriate quality checks, records, and follow-up actions.
  • Manage supplier and service provider qualification, quality agreements, audits, change management, deviations, CAPAs, and periodic reviews.

Requirements

  • Bachelor’s degree in Science or a related field.
  • Certified pharmacist license in Korea required.
  • 10–12+ years of experience in pharmaceutical and/or medical device quality operations.
  • Experience with QMS development and maintenance under Korean regulatory requirements and global quality standards.
  • Strong knowledge of GDP/GDPMD, cGMP, PIC/S, ICH, ISO standards, cold-chain operations, importation, testing, release, distribution, and repackaging.
  • Korean and English language proficiency required.

Culture & Benefits

  • Work within a global ophthalmology-focused organization with a long-term vision for improving outcomes for people with visual impairments.
  • Inclusive physical and virtual workplace with flexible ways of working.
  • Opportunity to collaborate with international teams and external healthcare and quality partners.

Hiring process

  • Submit a resume using the provided format template.
  • Submit application materials in both Korean and English.

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