Global Quality Solutions Representative II- #26-16476

Duration:12+ months 
Description:

Global Quality Solutions Representative tasks include:

• Support the optimization of quality systems by applying a process-centric approach to assess workflows, identify inefficiencies, and implement improvements that enhance consistency, compliance, and operational effectiveness.
• Partner with key stakeholders to evaluate system improvement needs, align enhancements to business objectives, and drive prioritization of initiatives to maximize value and efficiency.
• Collect, analyze, and translate business requirements into effective system configurations for TrackWise Digital (Quality Management System (QMS)) that meet user needs and compliance requirements.
• Support the evaluation, testing, and implementation of AI capabilities within quality systems.
• Facilitate meetings across different Quality areas, educate them on the latest Configuration of QMS processes and receive alignment across all sites for new enhancements.
• Provide frontline business support for requirements on QMS processes.
• Provide support for UAT testing.
• Establish strategic partnerships with key stakeholders within Global Quality and across the sites using the QMS System.
• Support the Global Quality users with system access management.
• Support specific innovation projects of relevance to the Global Quality Operations team and risk management as needed.
• Review validation documents (URS, FRS, workflow diagrams, etc.,) for accuracy during the system enhancement releases.
• Create training material for quality computer systems enhancements as needed.
• Define and implement data standards that support effective reporting, analytics, and cross-system integrations.
• Lead initiatives to improve data quality and maintain master data management practices.
• (UAT Activities)- Assist as needed in verification of system configuration and user acceptance testing for Enhancement Release.
• Collaborate with the Global Quality organization and cross-functional partners to create digital solutions to optimize and streamline processes as needed.
• Collaborate with IT on resolving any ongoing user issues with QMS.

Qualifications Experience:

• Bachelor’s degree preferably in a scientific discipline.
• 3 to 4 years of Pharma Quality related processes and Quality management systems experience is required.
• Knowledge of Pharma Quality Standards, TrackWise Digital and Computer system validation.

Required Skills Include:

• Ability to Influence stakeholders across functions.
• Ability to build partnerships with other functional leads.
• Ability to work effectively in a matrixed, multi-cultural, collaborative, and self-directed environment.
• Advanced analytical skills, and general understanding of the drug development and regulatory process is required.
• Knowledge of GxP areas.
• Knowledge of Computer System Validation.
• Exceptional oral and written communication skills.
• Experience with software applications that will be regularly used (in particular: TrackWise, Excel, SharePoint, PowerPoint, and MS Teams).

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.

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