QA Specialist

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to:

Location:

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What you will do

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.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.