Digital Quality Control

hace 2 meses

Tlahuac, México Novartis A tiempo completo

395287BR

**Digital Quality Control**:
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.

**Commitment to Diversity & Inclusion**:

- 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.

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.

**Division**

Operations

**Business Unit**

QUALITY

**Work Location**

Ciudad de México

**Company/Legal Entity**

NOV CORPORATIVO MEX

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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