4 дня назад
Assistant QC Operations Manager (1 year contract) (Pharmaceutical Quality)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Assistant QC Operations Manager (Pharmaceutical Quality): Managing quality operations for imported ophthalmology products in Korea with an accent on regulatory compliance, product testing, distribution quality, and quality management systems. Focus on coordinating laboratories and logistics providers, maintaining GMP/GDP/GSP compliance, supporting inspections and audits, and driving CAPA and quality improvement activities.
Location: Seoul, South Korea; on-site quality operations for products imported, tested, stored, released, and distributed in Korea.
Company
is a Japan-originated global life sciences company focused exclusively on ophthalmology, with operations in more than 60 countries.
What you will do
- Manage receiving inspections, shipment release approvals, import documentation, and defect investigations for imported products.
- Coordinate product testing with approved contract laboratories and maintain accurate quality documentation.
- Oversee warehouse, storage, distribution, environmental monitoring, inventory handling, and product disposition activities.
- Maintain and improve the local Quality Management System, including SOPs, training, deviations, CAPAs, change controls, risk assessments, metrics, and product quality reviews.
- Provide quality oversight of suppliers, distributors, 3PL providers, contract laboratories, and quality agreements.
- Support regulatory inspections, audits, pharmacist surveillance, product launches, technology transfers, and lifecycle changes.
Requirements
- Bachelor’s degree in Pharmacy or a related scientific discipline.
- Certified pharmacist license in Korea is required.
- Korean and English language proficiency is required.
- QA/QC experience in the pharmaceutical or medical device industry, including GMP manufacturing or commercial quality operations, is preferred.
- Knowledge of local regulations, GMP/GDP/GSP standards, and QMS for imported healthcare products is preferred.
- Experience with suppliers, distributors, 3PLs, external laboratories, inspections, audits, and compliance initiatives is preferred.
Nice to have
- Knowledge of PIC/S, ICH, ISO standards, cold-chain management, analytical method transfer, and import or wholesale operations.
Culture & Benefits
- One-year contract position with full-time employment.
- Flexible ways of working and an inclusive physical and virtual workplace.
- Opportunity to contribute to ophthalmology innovation and patient outcomes.
- Accommodation can be requested during the recruitment process.
Hiring process
- Submit a resume using the provided template.
- Submit application materials in both Korean and English.
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 →