대전 바이오 공장 신설 - Quality System Specialist (QA, QC, SAP QM module)

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

Your role:
 

Overall Objectives of the Position

• The Quality System specialist will be responsible for collection and maintenaince of SAP QM Material Master Data and Quality Inspection Plan and establish and update the SAP QM related system operation procedures.
• To ensure that all the business processes which are impacted by SAP master data and SAP QM system opertaion compliance with GMP requirement and without potential qualtiy risks.

Responsibilities

• Master data of SAP QM generation and maintenance, responsible verify the correction of GMP impacted fields in SAP and the final release material in SAP system.
• Master data of Quality Inspection Plan and MIC.
• Maintain SAP QM related operating procedures and documents.
• QM end user authorization management
• To provide technical training for New Functionalities or Users
• To provide Trouble shooting and technical support to QM end users.
• Initiate QM related Incident Management
• Consult Local Organization, Clarify Business Related Issues
• Participate quality related projects (SAP, LIMS, lean lab etc.) within quality department or cross functions, support to tasks related to CSV life cycle management.

Who you are:

Qualification:

• Bachelor Degree or above, major in pharmacy, biopharmaceutical, machinery or automation.
• At least 5 years’ QA or QC experience including 3 years’ SAP QM module in pharmaceutical plant, and experiences in the field of computerized system validation in the pharmaceutical industry.
• Familiar with GMP regulations/guides and quality management process.
• Fluent in English.
• Result orientation, accuracy and reliability as a must.

Excellent communication, problem-solving, and organization skills, attentive, careful and meticulous, with strong team-work ability

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!