395287BR
Apr 12, 2024
Mexico
About the Role
#LI#CDMX#Hybrid
As a Digital Quality Control Specialist, you will play a crucial role in our pharmaceutical company, supervising the implementation of Labware (GLIMS) in three Quality Control (QC) labs within the region. Your expertise in digital quality control systems, specifically GLIMS, will ensure the successful integration and utilization of Labware across these labs, ultimately supporting the improvement of our quality control processes.
Responsibilities:
•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, 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 detailed 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 implement to established protocols.
• Provide ongoing technical support and troubleshooting for Labware (GLIMS) users, addressing any issues or concerns promptly and reliably. Supervise and analyze data generated by Labware (GLIMS), identifying trends and potential areas for improvement in quality control processes.
• Collaborate with the Quality Assurance (Deviation handling .,CAPA definition,KPI trending -data integrity review and approval of analytical data / tests (analytical release) Stability testing (Projects) protocol preparation, evaluation, report preparation . -Reporting (Stability plan preparation, trend analysis, evaluation) Review and approval of analytical tests (analytical release) Microbiological QC Perform Microbiological testing of materials and utilities, environmental and personnel supervising .Provide expert Support for site qualification and validation activities. Maintain and calibrate equipment incl. plan preparation.
• Stay updated with the latest advancements in digital quality control systems, specifically Labware (GLIMS), and recommend improvements or additional tools to improve efficiency and effectiveness.
As a Digital Quality Control Specialist, you will play a crucial role in our pharmaceutical company, supervising the implementation of Labware (GLIMS) in three Quality Control (QC) labs within the region. Your expertise in digital quality control systems, specifically GLIMS, will ensure the successful integration and utilization of Labware across these labs, ultimately supporting the improvement of our quality control processes.
Responsibilities:
•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, 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 detailed 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 implement to established protocols.
• Provide ongoing technical support and troubleshooting for Labware (GLIMS) users, addressing any issues or concerns promptly and reliably. Supervise and analyze data generated by Labware (GLIMS), identifying trends and potential areas for improvement in quality control processes.
• Collaborate with the Quality Assurance (Deviation handling .,CAPA definition,KPI trending -data integrity review and approval of analytical data / tests (analytical release) Stability testing (Projects) protocol preparation, evaluation, report preparation . -Reporting (Stability plan preparation, trend analysis, evaluation) Review and approval of analytical tests (analytical release) Microbiological QC Perform Microbiological testing of materials and utilities, environmental and personnel supervising .Provide expert Support for site qualification and validation activities. Maintain and calibrate equipment incl. plan preparation.
• Stay updated with the latest advancements in digital quality control systems, specifically Labware (GLIMS), and recommend improvements or additional tools to improve efficiency and effectiveness.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
• Bachelor's degree in a relevant scientific discipline, such as Chemistry, Biology, or Pharmaceutical Sciences.
• Highly skilled and experienced laboratory professional who contributes by performing analytical release testing, investigational support, research support, and stability testing
• Proven experience in implementing and managing digital quality control systems, specifically Labware (GLIMS), within a pharmaceutical or biotech environment.
• 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.
• Meticulous 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 lead multiple projects simultaneously, ensuring timely completion of tasks.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
• Highly skilled and experienced laboratory professional who contributes by performing analytical release testing, investigational support, research support, and stability testing
• Proven experience in implementing and managing digital quality control systems, specifically Labware (GLIMS), within a pharmaceutical or biotech environment.
• 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.
• Meticulous 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 lead multiple projects simultaneously, ensuring timely completion of tasks.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Operations
QUALITY
Mexico
Ciudad de México
NOV CORPORATIVO MEX
Quality
Full Time
Regular
No
