- Lead the implementation and management of Labware (GLIMS), a global laboratory information management system, within three QC labs in the region, ensuring seamless integration and effective utilization of the system.
- Collaborate with cross-functional teams, including IT, QC, QA and lab personnel, to gather requirements, design workflows, and configure Labware (GLIMS) to meet the specific needs of each lab.
- Customize Labware (GLIMS) functionalities and workflows to streamline quality control processes, automate data management, and ensure regulatory compliance.
- Conduct thorough testing and validation of Labware (GLIMS) functionalities to ensure accuracy, compliance, and data integrity.
- Develop and maintain standard operating procedures (SOPs) for Labware (GLIMS) usage, ensuring that all lab personnel are trained on the system and adhere to established protocols.
- Provide ongoing technical support and troubleshooting for Labware (GLIMS) users, addressing any issues or concerns promptly and effectively.
- Monitor and analyze data generated by Labware (GLIMS), identifying trends and potential areas for improvement in quality control processes.
- Collaborate with the Quality Assurance team to ensure Labware (GLIMS) implementation aligns with regulatory requirements, including Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Stay updated with the latest advancements in digital quality control systems, specifically Labware (GLIMS), and recommend enhancements or additional tools to improve efficiency and effectiveness.
- Bachelor's degree in a relevant scientific discipline, such as Chemistry, Biology, or Pharmaceutical Sciences.
- Strong knowledge of quality control processes and regulations, including Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Proficiency in configuring and customizing Labware (GLIMS) workflows and functionalities to meet specific lab requirements.
- Excellent problem-solving skills, with the ability to troubleshoot and resolve technical issues related to Labware (GLIMS) implementation.
- Detail-oriented approach, ensuring accuracy and data integrity within the system.
- Strong communication and interpersonal skills, enabling effective collaboration with cross-functional teams and training lab personnel.
- Ability to work independently and manage multiple projects simultaneously, ensuring timely completion of tasks.
- Familiarity with regulatory requirements for digital systems in the pharmaceutical industry.
- Continuous learning mindset, keeping up-to-date with emerging trends and technologies in digital quality control systems, specifically Labware (GLIMS).
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Digital Quality Control specialist - México - Novartis Farmacéutica
Descripción
Qualifications
Join our team as a Digital Quality Control Specialist and contribute to enhancing our quality control practices by implementing and managing Labware (GLIMS) across our QC labs in the region. Your expertise in Labware (GLIMS) will be instrumental in maintaining compliance, accuracy, and efficiency within our quality control processes, ultimately supporting the delivery of high-quality pharmaceutical products.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
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Division Operations
Business Unit Pharmaceuticals
Location Mexico
Site INSURGENTES
Company / Legal Entity MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.
Functional Area Quality
Job Type Full time
Employment Type Regular
Shift Work No
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