Quality Assurance Specialist

The Quality Assurance Specialist ensures a robust and compliant PV Quality System with principal accountability for the assigned Quality Assurance workflows. This role serves as a quality leader and SME partnering with PV Operations and Celltrion, Inc. teams to prevent, detect, and correct quality issues while driving continuous improvement aligned with Good Pharmacovigilance Practice modules, ICH, EMA, FDA, and other Regulatory Authorities expectations.

Quality Management System (QMS)

• Manage annual and ad‑hoc periodic reviews of PV documents, ensuring timely updates and preventing overdue or outdated procedures within the PV Quality Management System.
• Monitor and trend compliance with procedural requirements through document KPIs, including on time review performance and training completion metrics.
• Provide coaching and support to document authors and PV stakeholders to improve document drafting quality, readability, and regulatory robustness.
• Collaborate closely with PV Operations to ensure procedures are aligned, consistent, efficient and compliant.
• Support audits and inspections by providing accurate document lists, revision histories, and evidence of controlled updates, ensuring full traceability of procedural changes and rationale.
• Support review of the Pharmacovigilance System Master File (PSMF).

Training

• Serve as the SME for the PV Trainings, ensuring compliance with GVP, ICH, and internal quality requirements.
• Manage the training curriculum development, role-based training assignments, monitoring, and documentation in the ELMS.
• Maintain and update training matrices based on procedural updates, role changes, system enhancements, and regulatory expectations.
• Ensure timely completion of onboarding, procedural, system, and audit/ inspection-readiness training activities.
• Conduct training gap analyses and ensure new or revised procedures are properly incorporated into training requirements.
• Develop and refine training materials, ensuring alignment with current PV practices and controlled documents.
• Maintain audit-ready training records with complete traceability and version control.
• Monitor training KPIs, compliance trends, and overdue rates for periodic review.
• Lead the training component of audit and inspection readiness, supporting SMEs and providing required training documentation.
• Collaborate with Operations team to ensure training needs are addressed proactively.
• Support onboarding of new PV staff and/or affiliates and provide coaching to junior QA staff and training coordinators.
• Drive continuous improvement of training workflows, LMS functionality, and training effectiveness to enhance operational readiness.

Audits & Inspections

• Support internal PV audit planning and execution, including defining scope, developing agendas, identifying sampling strategies, and contributing to audit reporting.
• Partner with PV Operations in audit readiness activities, such as coordinating storyboards, preparing documentation for war rooms, aligning SMEs for topic-specific inquiries, conducting

mock interview sessions, etc. to ensure consistent, compliant responses.

• Assist the QA Team Lead during audits and inspections by working jointly with PV Operations to manage document requests, track submissions, and ensure responses are accurate, aligned, and supported by contemporaneous records.
• Coordinate with PV Operations on the development of audit/inspection responses, ensuring CAPAs address operational gaps effectively and verifying the successful implementation and effectiveness of corrective actions.
• Support the development and maintenance of the internal PV Audit Schedule by participating in the risk-based assessment ensuring operational trends, system changes, and historical findings are appropriately factored into audit planning.

Deviation & CAPA Management

• Lead and serve as SME for all deviations and CAPA activities, ensuring compliance with GVP and internal quality standards.
• Facilitate structured RCA to identify true system-level root causes and ensure evidence-based investigations.
• Lead trend analysis to identify recurring issues, systemic gaps, and emerging risks, and develop preventive or corrective process improvements.
• Prepare and maintain deviation/CAPA dashboards, metrics, and reports for PV quality reviews and audit and inspection readiness.
• Partner cross-functionally to implement process improvements and strengthen PV quality culture.
• Support audit and inspection readiness related to deviation and CAPA processes.
• Collaborate with CGSDCI and Celltrion Headquarters to ensure deliverables are met in a timely manner.
• Establish work priorities and direction independently with minimal input from Quality Assurance Team Lead.
• Directly report to QA Team Lead the PV QA deliverables.
• Other duties as assigned by the Quality Assurance Team Lead

General

1. A total professional work experience of at least 3 years including 2 years experience in pharmacovigilance of which at least 1 year in pharmacovigilance Quality Assurance
2. Fluent in English; Knowledge in additional language(s) is an advantage.
3. Excellent interpersonal [verbal/written] communication skills.
4. Excellent organizational and prioritization skills.
5. Ability to work in a fast-paced pharmaceutical environment needed.
6. Ability to work collaboratively and effectively in a team environment.
7. Ability to be detail oriented and work under minimal supervision to solve routine problems or issues constructively.
8. Ability to make decisions with an understanding of the consequences
9. Must maintain all levels of confidentiality and have a professional, positive attitude towards the job

Competencies

• Experience with computer applications including database management and pharmacovigilance systems currently utilized by CGSDCI.
• Able to independently perform tasks within the Microsoft Office suite without additional

need for basic training.

• Basic medical knowledge.
• Intermediate knowledge in pharmacovigilance concepts with good grasp on the company's internal conventions.