Job Description of QC LIMS SMEReport to: QC Manager s: The QC LIMS (Laboratory Information Management System) SME (Subject Matter Expert) will play a pivotal role in the LIMS project, providing subject matter expertise and acting as a key liaison between the Quality Control department and the project team.
The role involves in-depth knowledge of QC processes, LIMS/SAP system. Provide expert guidance on QC processes and workflows to ensure seamless integration with the LIMS.
Collaborate with cross-functional teams to gather and analyse requirements for the LIMS project.
Act as a bridge between QC users and Global and Local IT teams to ensure the LIMS meets the specific needs of the QC department.
Contribute to the design, configuration, and testing of the LIMS including the scope of integration with SAP system, ensuring it aligns with regulatory and compliance standards.
Train QC users on LIMS functionalities and best practices.
Provide ongoing support and maintenance for the LIMS post-implementation.
Take responsibilities in assigned LIMS projects as appropriate. Who you are: Minimum bachelor’s degree in a relevant scientific field.
A minimum 5 years of experience in Quality Control within the pharmaceutical, life science, or related industry.
Proven expertise in LIMS systems, including configuration, validation, and support.
Experience in building/developing LIMS system to establish QC laboratory will add value.
Strong project management skills with a track record of successful project participation.
In-depth knowledge of regulatory requirements (e.g., GMP, FDA, EMA) related to QC and LIMS.
Excellent communication and stakeholder management skills.
Preferred Skills: Experience with specific Global LIMS platforms Knowledge of laboratory automation and integration with LIMS.
Fluent in English.
광고
Qc Lims Sme (lab Qc / Lims 사용 경험자), Daejeon
Free
Qc Lims Sme (lab Qc / Lims 사용 경험자), Daejeon
Korea South, 대전, 대전,
게시됨 August 16, 2024
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