15 часов назад
Assistant QC Operations Manager (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 product testing, QMS governance, regulatory compliance, and supplier oversight. Focus on maintaining GMP/GDP/GSP compliance, supporting inspections and audits, and coordinating quality activities across laboratories, distributors, and logistics providers.
Location: Seoul, South Korea
Company
is a Japan-originated life sciences company focused exclusively on ophthalmology, providing eye care treatments and digital solutions across more than 60 countries.
What you will do
- Manage quality operations for imported products, including receiving inspections, shipment release approvals, import documentation, and defect investigations.
- Coordinate product testing with approved contract laboratories and maintain accurate quality documentation.
- Oversee warehouse, storage, and distribution quality activities, including GDP/GSP compliance, environmental monitoring, inventory handling, and product disposition.
- Maintain and improve the local Quality Management System, including SOPs, training, deviations, CAPAs, change controls, risk assessments, quality metrics, and product quality reviews.
- Provide quality oversight for suppliers, distributors, 3PL providers, contract manufacturers, and external laboratories.
- Support regulatory inspections, audits, pharmacist surveillance, product launches, technology transfers, and product lifecycle changes.
Requirements
- Bachelor’s degree in Pharmacy or a related scientific discipline; licensed pharmacist qualification is preferred.
- At least 8 years of QA/QC experience in the pharmaceutical or medical device industry, including GMP manufacturing or commercial quality operations.
- Strong knowledge of local regulatory requirements, GMP, GDP, GSP, and QMS for imported healthcare products.
- Experience overseeing suppliers, distributors, 3PL providers, contract manufacturers, and external laboratories.
- Experience supporting regulatory inspections, audits, pharmacist surveillance activities, and compliance initiatives.
- Fluency in Korean and English is required; travel may be required for quality operations and audits.
Nice to have
- Knowledge of PIC/S, ICH, and ISO standards.
- Experience with cold chain management, analytical method transfer, and import or wholesale operations.
Culture & Benefits
- Work within a global ophthalmology-focused life sciences organization with a long-term vision for improving outcomes for people with visual impairments.
- Inclusive physical and virtual workplace.
- Flexible ways of working.
- Reasonable accommodation is available during the recruitment process.
Hiring process
- Submit a resume using the provided format template.
- Submit application materials in Korean and English, or in Korean.
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