## [Quality Assurance Specialist](/req-10087642-quality-assurance-specialist "Quality Assurance Specialist") Job ID REQ-10087642 Sep 16, 2026 LOC_KR ### About the Role Major Accountabilities - Accountable for product compliance to local/international regulations as well as Novar tis Corporate Quality Policy. - Ensure that all drug products are released to the market in a timely manner in accordance with the registered specifications and with local/international regulations. - Manage the effective Change Control process. - Manages the documentations and archiving of QA data and records to be compliant with local regulations, Novartis Corporate guideline and GMP requirements. - Conducts the review of the accordance between the analytical testing specifications/methods and registered product license. - Performs management of analytical method transfer and analytical testing documents transfer complied with both Novartis QM/QD and relevant SOPs under pharmaceutical law. - Manage external inspections, complaints, deviations, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures and implement each CAPA timely. - Manage technical complaints including reporting to appropriate investigation sites, managing investigation processes, and ensuring that appropriate corrective actions are taken. - Identifies and reports any quality or compliance concerns and implementation of immediate corrective action as required - Ensures the readiness for escalation including prompt decision and actions of recall / Market action. - Report monthly Key Quality Indicators (KQIs) and monitor them and assure that gaps are addressed appropriately in order to mitigate risk. - Establish a good working relationship with the Supply Chain Management (SCM) / RA departments as well as External Supply Organization (ESO) allowing to keep QA oversight on all partners (e.g. third-party activities). - Ensures that returned and defective products are managed and disposed in accordance with GMP requirements. - Ensure reporting and follow up of all spontaneous adverse events (AE) and technical complaints for all Novartis Corporate products according to respective SOP. Key Performance Indicators (KPIs) - Local GMP Quality System in place and continuously updated, as required - GMP related risks proactively identified and effectively mitigated - The number and severity of GMP issues identified during internal and external audits - No regulatory problem/action due to inefficient local Change Control procedure - Training conducted according to program Education - Degree in Life Sciences or related fields (Pharmacy preferred) Language - Good command in English (speaking and writing) Experience - Min. 3 year experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, production or a directly related area - Strong Interpersonal skills - Strong Project Management and leadership skills - Ability to work under pressure and matrix organization - Highly proficient in negotiation skills - Highly effective in influencing others ### Role Requirements **Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? [https://www.novartis.com/about/strategy/people-and-culture](https://www.novartis.com/about/strategy/people-and-culture "https://www.novartis.com/about/strategy/people-and-culture") **Benefits and Rewards:** Learn about all the ways we’ll help you thrive personally and professionally. [Read our handbook (PDF 30 MB)](https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf) Division DIV_TO Business Unit Quality Location LOC_KR Site Seoul Company / Legal Entity KR01 (FCRS = KR001) Novartis Korea Limited Functional Area FCT_QA Job Type Full time Employment Type Regular Shift Work No [Apply to Job](https://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Seoul/Quality-Assurance-Specialist_REQ-10087642 "Apply to Job") ![careers default image](https://prod1.jobapi.novartis.com.cn/themes/custom/cosmos/patterns/images/careers-default-image.webp "careers default image") Job ID REQ-10087642 ### Quality Assurance Specialist [Apply to Job](https://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Seoul/Quality-Assurance-Specialist_REQ-10087642 "Apply to Job")