QC Expert

Hiring By - Biostaffic

 BioPharma

China

Job Highlights

Not Disclosed

Posted 4 months ago
Job details
At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
QC Expert
Your Tasks And Responsibilities
Be responsible for the management procedures on safety and quality affairs, to make sure they can be implemented in different labs consistently and efficiently and continues to optimize them. Promote the implementation of high efficiency and lean management in QC. Mainly including but not limited to the following points:
  • Responsible for designing continuous improvement on QC e.g., PSS activity, reduction complexity and efficiency aspects in Quality Control area and ensure implementation in the shop floor. Ensure all level of strategy and operation improvement projects/tasks from global level, site level and department level be well understood, executed, and realized. The scope includes but notlimit to:
  • Digital projects
  • Lean Lab related projects.
  • Lab operation management system related projects
  • Training Management
  • Responsible and coordinating for development, verification, and assess safe and robust for analytical method transfer and analytical method validation within QC area based on QbD, manage, and ensure smooth hand over of analytical method by checking all relevant technical.
  • Coordinate the general QC lab's management and key operational procedures, pointed out the on-site optimization points during regular internal Gemba, give proper approaches and promote the implementation to ensure the QC procedure runs in a compliant way.
  • Review local analytical methods, specifications, SOPs to ensure they are compliance with Pharmacopeia and register dossier documents. Evaluate and update documents according change control management requirements and review all the documents for their compliance regularly.
  • Participate in the investigation on deviations and OOS based on business requirements. Support management relevant control change plan and risk assessment to ensure meeting the compliance and business requirement.
  • Support the compliance work from QA, RA, or other departments. e.g., QSR, PQR, submission dossier and CMS etc.
  • As QC Expert, participant in self-inspection, Global and official audit as QC SME. Coordinate and support the risk assessment and CAPA of findings.
  • Lead and participate in QC optimization project of Global to promote the achievement of strategy objectives on QC lean efficient management.
  • Strictly follow regulation/SOP requirements, execute the operations with GMP commonsense, fulfil Data Integrity requirements every time, all the time. Point out the activities or issues which is not compliance, report to manager in timely manner.
  • Other tasks assigned by line manager.
Who You Are
  • Bachelor's degree or above in Analytical chemistry or Pharmacy related majors
  • 8+ years pharmaceutical manufacturing experience
  • Familiar with Pharmacopeia, e.g., CP, EP and USP etc.
  • Written English and Oral English are required.
  • Result orientation, accuracy, and reliability as a must
  • Strong team spirit, Excellent communication, problem-solving, planning and organization skills.
YOUR APPLICATION
If your background and personal experience fit this profile, please send us your complete application at www.career.bayer.cn If you have any recommendations, please kindly send mail to cnreferral@bayer.com
L ocation:
China : Jiang Su : NanTong
Division:
Consumer Health
Reference Code:
806683

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • China

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 17, 2024
Company Overview
拜耳
拜耳

Current Openings: 0

Bayer ist ein weltweit tätiges Unternehmen mit Kernkompetenzen auf den Life-Science-Gebieten Gesundheit und Agrarwirtschaft. Mit unseren Produkten und Dienstleistungen möchten wir den Menschen nützen und zur Verbesserung der Lebensqualität beitragen. Gleichzeitig haben wir das Ziel, Werte durch Innovation, Wachstum und eine hohe Ertragskraft zu schaffen. Mit unseren Produkten tragen wir zur Lösung großer Herausforderungen unserer Zeit bei. Dazu zählen die wachsende Weltbevölkerung, eine älter werdende Gesellschaft sowie die effiziente und möglichst nachhaltige Nutzung natürlicher Ressourcen. Gemäß unserer Mission „Bayer: Science For A Better Life” wollen wir die Lebensqualität der Menschen verbessern, indem wir Krankheiten verhindern, lindern und heilen. Wir tragen zu einer ausreichenden Versorgung mit qualitativ hochwertigen Lebens- und Futtermitteln und nachwachsenden pflanzlichen Rohstoffen bei. Wir setzen dabei vor allem auf die Entwicklung und erfolgreiche Vermarktung von innovativen Produkte und Lösungen, die auf wissenschaftlichen Erkenntnissen basieren. Datenschutzerklärung und Impressum: https://www.bayer.com/en/glob-li-bayer-en-dps-imprint.aspx
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