Quality Assurance Specialist

About the role

Novartis is looking for a Quality Assurance Specialist in Seoul to ensure that finished products imported and distributed by the country organization comply with the Korea Pharmaceutical Law and related regulations, as well as with the Novartis Corporate Quality Manual and policies, including cGxP requirements. The role covers product release, change control, documentation, inspections, complaints and CAPAs.

Key responsibilities

• Ensure all drug products are released in line with registered specifications and local/international regulations.
• Manage the Change Control process and the documentation and archiving of QA data and records in line with local regulations, corporate guidelines and GMP requirements.
• Review analytical testing specifications and methods against the registered product license, and manage analytical method and testing document transfers.
• Manage external inspections, complaints, deviations, recalls, counterfeits and product tampering, and implement CAPAs on time.
• Handle technical complaints, investigations and reporting of spontaneous adverse events, and report monthly Key Quality Indicators.
• Work with Supply Chain Management, Regulatory Affairs and external supply organizations to maintain QA oversight, and ensure returned and defective products are handled in line with GMP.

Required profile

• Degree in Pharmacy; Registered Pharmacist in Korea is required.
• Minimum 3 years of experience in the pharmaceutical industry in QA, QC, registration, production or a related field.
• Good command of spoken and written English.
• Strong interpersonal, project management and leadership skills, ability to work under pressure in a matrix organization, and strong negotiation and influence skills.

Required skills

• GMP compliance and Quality Management Systems (QMS)
• Audit inspections and regulatory compliance awareness
• Data integrity and data literacy
• Change adoption and process optimization