QA Specialist

QA Specialist

Lo que hacemos

En Kenvue, nos damos cuenta del extraordinario poder del cuidado diario. Sobre la base de más de un siglo de herencia y arraigados en la ciencia, somos el hogar de marcas icónicas, incluidas NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® y BAND-AID® que ya conoces y amas. La ciencia es nuestra pasión; El cuidado es nuestro talento.

Quiénes somos

Nuestro equipo global está formado por ~ 22.000 personas brillantes con una cultura laboral en la que cada voz importa y cada contribución es apreciada. Nos apasionan las ideas, innovación y comprometidos con la entrega de los mejores productos a nuestros clientes. Con experiencia y empatía, ser un Kenvuer significa tener el poder de impactar a millones de personas todos los días. Ponemos a las personas en primer lugar, nos preocupamos ferozmente, nos ganamos la confianza de la ciencia y resolvemos con coraje, ¡y tenemos oportunidades brillantes esperándote! Únase a nosotros para dar forma a nuestro futuro y al suyo. Para obtener más información, haga clic en aquí.

Role reports to:

Sr. Commercial Quality Specialist

Ubicación:

Asia Pacific, South Korea, Seoul, Seoul

Lugar de trabajo:

Híbrido

What will you

As Qualified Person (QP), this position is responsible for Quality Release and Management activities of imported OTC products and distribution operation.

[Responsibilities]

• Final batch release as Qualified person (QP).

• Manage the quality inspection and test activities of imported OTC products including incoming inspection of products and release testing.

• Manage QA activities for imported OTC products release from End to End, incoming inspection, sample shipment arrangement, release checklist preparation and so on.

• Oversee the new product introduction process including test method transfer, QC tests, change control management and related documents preparation.

• Implement the Quality System via transposition of the requirements of the Commercial Quality procedures.

• Execute requirements regarding lifecycle management of GxP related documents and records (creation, approval, distribution, revision, retrieval, retention, disposition) to ensure regulatory compliance and business continuity.

• Update and keep GxP documents up to date on EDMS.

• Participate in the product performance related issue handling and product nonconformance with collaborating with cross functional quality teams.

• Ensure appropriate Change control/Deviation/CAPA/Effectiveness check procedures are followed. Monitor quality records status for timely closure and support issues using QMS.

• Ensure a review of the APQRs as required by local regulations.

• Support product complaint management.

• Support internal audit and HA inspection for auditing and documentation

• Support supplier qualification and document management.

 

What we are looking for

[Requirements]

• Bachelor’s degree in Pharmacy and pharmacist (Mandatory)
• At least 2-4 years of experience preferred in the Pharmaceutical or related industry, ideally with QA & QC operations.
• Fluency in English and Korean (spoken and written)

[Preferred Qualifications]

• Good communication skills (verbal and written) to operational and leadership employee levels, of external partners, suppliers, third parties, and industry organizations.
• Excellent interpersonal skills and partnership attitude, using a team-oriented approach to ensure timely delivery of plan and resolve problems for complex issue in a scientifically sound and understandable way.

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