Jr. Quality Assurance Specialist
I. Duties
The primary focus of the Junior Quality Assurance Specialist is to operate and support Quality Assurance activities in accordance with Korea Good Importing Practice (KGIP) and Korea Good Supply Practice (KGSP). This role performs operational product quality management at outsourced warehouses and maintains relevant quality documentation in line with Servier standards and applicable local requirements, under the guidance of the supervisor and/or Senior Quality Assurance Specialist. The Junior Quality Assurance Specialist also provides administrative support within the Quality Assurance area, including KGIP/KGSP documentation and record filing.
Job Description
Candidate Profile
II. MAIN RESPONSIBILITIES
- Warehouse Quality Operations (KGIP/KGSP)
- Operate product quality activities at outsourced warehouses (incoming, storage, release, and distribution) in accordance with local requirements and Servier procedures.
- Perform incoming control (e.g., review and inspection of incoming products, verification of incoming checklists, and review of temperature/humidity monitoring logs).
- Review warehouse documentation (e.g., Warehouse 1 and 2), check storage conditions, sanitation and segregation status, and manage retention/QC samples as applicable.
- Monitor warehouse environmental controls (e.g., temperature mapping/monitoring and data loggers) and support cold-chain operations for temperature-sensitive products where applicable.
- Support third-party quality oversight of warehouse/logistics partners that may impact product quality (e.g., warehousing, redressing, distribution) under the operational guidance of the QA Specialist.
- Quality Documentation & QMS Support
- Maintain and file KGIP/KGSP documentation, including relevant parts of the product master file and product control records related to warehouse operations.
- Support local SOP/OPM and quality record management: understand and implement local SOPs/OPMs; support creation/revision and training activities in alignment with Servier standards and local requirements.
- Ensure QA and warehouse-related records are archived securely and retained in accordance with Korean regulations and Servier requirements.
- Compliance, Training & Inspection Support
- Monitor and report quality/compliance issues observed at warehouses to the supervisor and/or Senior Quality Assurance Specialist; support follow-up actions as instructed.
- Perform KGIP/KGSP compliance activities, including self-audits, participation in KGIP/KGSP training, mock recall implementation, and preparation/support during regulatory authority inspections of warehouses/KGIP.
- Maintain awareness of current Korean legislation related to product quality management and complete required GxP training.
- Perform training activities and related documentation (including training records) for relevant stakeholders such as warehouse and logistics staff, as applicable.
The Junior Quality Assurance Specialist works closely with the Senior Quality Assurance Specialist, Supply Chain, warehouse/logistics partners, and other internal stakeholders to support QA oversight of activities impacting product quality. The role maintains up-to-date knowledge of applicable Korean regulations related to KGIP/KGSP and warehouse quality operations, as well as relevant Servier standards and procedures.
The Junior Quality Assurance Specialist is responsible for performing other related duties and special projects as assigned by department head, General Manager, and/or Servier Group.
III. Qualifications
- Bachelor’s degree in a scientific discipline (e.g. Pharmacy, Chemistry, Biology, Life Sciences, or a closely related field)
- Recent graduates with a relevant degree above who completed internship in the QA or QC experience in a cGMP or GIIP regulated environment is also qualified and encouraged to apply.
- 1 to 2 years of quality assurance (QA) or quality control (QC) experience in a cGMP or GIP regulated environment (Experience with KGIP/KGSP operations is preferred)
- Moderate level of written and spoken English communication skills
Must have a valid driver’s license and own a vehicle; on-site visits to the warehouses are required.
- Work Location : Seoul office / Warehouses (Chuncheon/Gunpo) 2~3 days / week
- Work Type : 1-year Direct Contract (Possibility of additional 1-year extension based on performance)