Sr Spec, Quality Assurance
Seoul, KR
3 일 전

Are you looking for a career that matters?

We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today.

We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them.

We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

Management of Field action and Medical device reporting and product release

  • Plans and schedules the work of QA Analysts, QA Technicians
  • Ensures that all inspection and test procedures are properly completed and documented.
  • Reviews all quality assessment results and determines whether to accept or reject imported products during the release process.
  • Coordinates the timely release of licensed products and Packaging according to schedule.
  • Develops and maintains inspection documentation procedures, QA inspection instructions and department policy procedures.
  • Ensures product compliance regulations are followed.

  • Responsible for change control activities / documentation. Required to perform review of regulatory documentation applicable to the product of the department.
  • Coordinates customer complaint response and tracking.
  • Responsible to evaluate returned goods from customers and review documents related to warehouse control(temperature, housekeeping and pest control etc).
  • Able to perform lead supplier audits as required and able to coordinate overseas GMP audit by KFDA
  • Support Korea quality team in identifying solution to meet regulatory and quality requirements from internal and external regulations.
  • To maintain awareness of regulatory and quality requirements and evaluate potential impact to Baxter operations.

  • Support Quality Manager to manage KGSP (Korea Good Supply Practice) requirements with warehousing and delivery suppliers.
  • To support and back up the quality manager during his / her absence
  • Qualifications

    Must have a Written and verbal communication skills in Korean & English Knowledge of applicable regulations (e.g. GMP, Korea Pharmaceutical & Device Laws) Stays confident when challenged, stating the rationale for one’s viewpoint clearly while listening to and respecting others right to different opinions Interpersonal Skills & Influence Adapts communication style to the audience in order to be heard Demonstrates organizational awareness and experience working on cross functional teams and in developing collaborative relationships with other teams and individuals

    Education / Experience

    Bachelor’s degree in Pharmacy with a minimum of 5 years of experience in a pharmaceutical company, or similar organization

    Bachelor's Degree ( 16 years) - Pharmacy

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