Baxter
Healthcare
SeniorSpecialist,QualityAssurance
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Specialist, Quality Assurance at Baxter. Skills: GQP, GMP, QMS. Manage GQP activities. Operate GQP activities”
Industry & Context.
Analytical skills
What They're Looking For.
Must Have
Minimum 5 years pharmaceutical quality experience, CMO management experience
Nice to Have
University degree in medical/pharmaceutical fields, Pharmacist license, Experience in generic drug QA
What You'll Do.
Manage GQP activities
Operate GQP activities
Manage GMP activities
Operate GMP activities
Handle GMP/QMS compliance inspections
Perform quality assurance pharmaceuticals
Perform quality assurance medical devices
Plan self-inspections
Arrange self-inspections
Monitor self-inspections
Report self-inspections
Arrange internal audits
Monitor internal audits
Report internal audits
Handle authority audits
Handle corporate audits
Manage contract manufacturing organizations
Perform GMP oversight
Manage change control
Manage non-conforming product
Communicate with manufacturing sites
Maintain Medical Device Files
Maintain Quality Standard Books
Maintain Product Standard Books
Support new product introduction
Full Job Description
**This is where** your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. **Job Summary /****業務概要** * Management and operation of GQP and GMP-related activities 医薬品の品質管理業務（GQP）の管理と運営、及び医薬品品質システム（GMP）に関する業務全般 * Management and operation of QMS 医療機器の品質管理監督システム（QMS）の管理と運営 * Handling GMP/QMS compliance inspections 医薬品及び医療機器のGMP/QMS適合性調査の管理と対応 * Quality assurance of pharmaceuticals and medical devices 医薬品及び医療機器の品質保証業務 * Self-inspections, internal audits, and external audits 自己点検、内部監査、外部監査対応 **Essential Duties & Responsibilities / ****担当業務詳細** **1\. GQP & GMP Management / ****医薬品のGQP****・GMP****管理** * Manage, operate, and maintain GQP 医薬品の品質管理業務（GQP）の管理、運営、維持 * GMP oversight for domestic and overseas manufacturers 国内外の製造業者のGMP対応 * Manage contract manufacturing organizations (CMOs) 医薬品製造受託機関（CMO）の管理 **2\. QMS Management /****医療機器のQMS****管理** * Manage, operate, and maintain QMS 医療機器の品質管理監督システム（QMS）の管理、運営、維持 **3\. GMP/QMS Compliance Inspections /****適合性調査対応** * Application, coordination, and execution of inspections 調査申請、行政窓口、問い合わせ、手配、実施対応 **4\. Quality Assurance Activities /****品質保証業務** * Quality assurance of assigned products 担当製品の品質保証業務 * Change control / 変更管理の対応 * Non-conforming product management / 不適合製品の措置管理 * Communication with manufacturing sites / 製造所とのコミュニケーション * Maintenance
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