Sr. Quality Assurance Specialist

I.      Duties

The primary focus of the Senior Quality Assurance Specialist is to ensure that quality of finished products imported and distributed by Servier Korea complies with local laws/regulations and Servier Group Standards, including cGxP requirements. This role also manages product quality at the warehouse and ensures adherence to applicable local regulations and Servier Group Standards.

II.    MAIN RESPONSIBILITIES

1. Product Quality Management

• Batch release: ensure all drug products are released to the market in accordance with the registered specification and local requirements. Approve batch release of Servier Korea products (when the Senior Quality Assurance Specialist is a licensed pharmacist) by reviewing local quality control data and supporting analytical method/testing document transfer activities where applicable, in accordance with Servier procedures and local requirements.
• Warehouse oversight: perform product control and management at the warehouse for incoming, storage, release, and distribution of finished products; manage warehouse environmental control.
• Third-party oversight: provide third-party quality oversight of warehouse leasing companies, 3PLs, and/or local distributors that have a direct impact on product quality (e.g., warehousing, redressing, distribution), including audits/qualification as applicable.
• Cold chain management: monitor temperature data (e.g., data loggers) and support qualification/validation of thermal packaging for temperature-sensitive products where applicable.
• KGIP/KGSP documentation: maintain KGIP documents, including corresponding parts of the product master file and product control records for warehouse operations.

2. Quality Management System for Korea and North Asia Cluster

• Local Quality Management System (QMS) governance: establish and maintain the Affiliate QMS compliant with cGxP and relevant local requirements (including KGIP/KGSP) and aligned with Servier Group Standards, ensuring governance, implementation, and continuous improvement of local quality processes.
• SOP & document management: review Servier Group Quality Standards for gap assessment and develop/update local SOPs/working instructions as required; ensure document control is compliant with cGxP and aligned with Servier Group Standards.
• QMS expansion to North Asia Cluster: lead the expansion of the QMS to the North Asia Cluster (Korea/Taiwan/Hong Kong) and assume responsibility for cluster QMS implementation, maintenance, and continuous improvement.

3. Quality Compliance

• Deviation, change control & CAPA: manage and trend deviations, change controls, and CAPA for activities that may impact product quality, compliance, patient safety, or supply.
• Recall & market actions, complaints and counterfeits: manage product quality complaints and coordinate investigations with relevant sites/partners; manage recalls/market actions and ensure traceability and recall readiness; manage counterfeit, returned, and defective product cases in accordance with procedures.
• Annual quality reviews: coordinate and/or support Annual Product Quality Review (APQR) inputs and local APQR activities as planned, including trending.

• Compliance monitoring & escalation: monitor quality compliance status and report significant quality issues to the department head; ensure quality processes are implemented accurately and consistently.

• Inspection readiness: manage internal and external inspections/audits and maintain inspection readiness; ensure timely responses and CAPA completion.
• Records & data integrity: ensure QA documentation, archiving, and retention of quality data/records are compliant with local regulations and Servier requirements, including data integrity.
• Training: plan and support GxP training activities (including KGIP/KGSP) and support evaluation of training effectiveness; educate relevant stakeholders (e.g., warehouse and logistics staff) on quality requirements as applicable.

The Senior Quality Assurance Specialist works closely with Supply Chain, Regulatory Affairs, Pharmacovigilance, and relevant partners to maintain QA oversight of activities impacting product quality.

The role maintains up-to-date knowledge of current Korean legislation relevant to product quality management (including the Pharmaceutical Affairs Act and related regulations), as well as applicable Servier Group Standards and cGxP requirements.

The Senior Quality Assurance Specialist is responsible for performing other related duties and special projects as assigned by the department head and/or Servier Group Quality.

III.    Qaulifications

• Bachelor’s degree or higher in a relevant field, Pharmacy, Pharmaceutical Science, Chemistry, Biochemistry, Biotechnology or a related discipline (Licensed pharmacist is preferred and will be responsible for batch release)
• Minium 5 years of quality assurance (QA) or quality control (QC) experience in a cGMP or GIP regulated environment (Experience in MNC Pharma company is preferred)
• Experience with KGIP/KGSP operations  
• Cold chain management experience (temperature monitoring, data loggers)
• Experience conducting audits and vendor qualification for 3PLs/warehouses/distributors
• Experience working in a multi-country setup (e.g., cluster QMS) and collaborating with global HQ is highly preferred
• Strong English communication skills: capable of writing and reviewing QMS documents/SOPs in English and discussing quality topics in cross-functional regional meetings

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) 1 ~ 2 days / week