Quality Assurance Specialist

[ZP Therapeutics]Zuellig Pharma is a leading healthcare solutions company in Asia, and our purpose is to make healthcare more accessible to the communities we serve. We provide world-class distribution, digital, and commercial services to support the growing healthcare needs in this region.The company was started a hundred years ago and has grown to become a multibillion-dollar business covering 17 markets with over 12,000 employees. Our people serve more than 200,000 medical facilities and work with over 450 clients, including the top 20 pharmaceutical companies in the world.Purpose of The Role:Establish, implement, and maintain the Quality Management System (QMS) for marketed healthcare products (Medicinal Products and Quasi-drugs) in strict compliance with South Korean regulations—including the Pharmaceutical Affairs Act, Good Import Practices (GIP), and Korea Good Supply Practices (KGSP)—and regional corporate policies.This position serves as the legally designated Import Control Pharmacist, holding ultimate responsibility for local batch release, post-market surveillance, and the quality integrity of products registered under company and clients.

What You’ll Do

1. Regulatory Compliance & Legal RepresentationAct as the legally registered Import Control Pharmacist and Qualified Person (QP) reported to the Ministry of Food and Drug Safety (MFDS).Ensure absolute compliance with the Korean Pharmaceutical Affairs Act, Good Import Practices (GIP), and KGSP standards across all operations.2. Import Quality Control & Local Batch ReleaseManage and execute product clearance and local batch release activities in accordance with Korean Import Control Standards and Good Supply Practices.Oversee and evaluate Local Batch Records and Certificates of Analysis (CoA) from manufacturing sites to authorize market distribution.Supervise contracted external laboratories for local QC testing, ensuring compliance with MFDS-approved specifications, test methods, and seamless technology transfer.3. Korea Good Supplying Practices (KGSP) & Distribution QAEstablish, maintain, and continuously improve the local QMS aligned with KGSP and ISO9001:2015 standards.Oversee the storage, handling, and distribution environment (including cold chain management) to prevent product degradation and contaminationManage life-cycle documentation via the Document Management System (DMS) to ensure data integrity and inspection readiness4. Post-Market Vigilance & Quality Risk ManagementLead the investigation and handling of product deviations, product complaints, and Product Quality Reviews (PQR)Establish root cause analysis (RCA) and implement robust Corrective and Preventive Actions (CAPA) for any quality discrepancies.Manage product recall procedures, mock recalls, and quality defects to the MFDS in a timely manner.5. Audit, Inspection & Stakeholder GovernanceServe as the primary liaison and host for regulatory inspections by the MFDS, regional authorities, and external client audits.Plan and conduct internal GxP/KGSP audits as well as initial and periodic qualifications of local third-party logistics (3PL) providers and vendors.Partner with Supply Chain operations to identify, escalate, and mitigate significant third-party quality risks to Regional Quality leadership.Develop and deliver mandatory regulatory and GxP training programs for local personnel.Must-Have:A valid Korean Pharmacist license is mandatoryEducation : Bachelor’s degree or above (major in pharmacy)Language : Fluent in English in written and verbal communicationTechnical : Computer literate (proficiency in MS Office)Advantage to Have:Experience :1) At least 3 years of regulatory, manufacturing, or quality assurance experience in the pharmaceutical industry.2) Proven experience hosting or participating in regulatory audits (MFDS) and corporate compliance audits.3) Hands-on experience in batch release within manufacturing sites or importing companies.Ability to work independently and prioritize workload.Excellent oral and written communication skillsStrong interpersonal skills with an ability to enable and drive change.Strong problem identification and problem-solving skillsExperience working with multi-functional teams.Strong commitment to core corporate values: Collaboration, Innovation, Integrity and Trust, Passion for Excellence, and Personal GrowthWorking Conditions:Legal Entity: ZP TherapeuticsType of contract : Fixed-term(18 months, replacement for parental leaves,)Location : Head Office (서울시 용산구 한강대로 92, LS타워 3층)Working hours : 09:00 – 18:00

What We Offer

We are committed to fostering an inclusive environment where our employees can learn, grow, and achieve shared success.We champion diversity, equity, and inclusion, ensuring every individual feels valued, respected, and treated fairly.As a leading multi-market healthcare solutions provider, we empower our employees to gain comprehensive knowledge and expertise in the dynamic healthcare industry across the region.Enjoy the flexibility to effectively balance your work and personal life while taking charge of your career journey through our empowering growth opportunities.Our Total Rewards program is designed to support your overall well-being in every aspect.