Senior Quality Process Manager

1 week ago


Coppell, Texas, United States DPS Group LLC Full time

About the Role
DPS Group LLC is seeking a Senior Quality Process Manager to lead quality aspects of design, installation, commissioning start up and validation of manufacturing systems, processes, products and facilities in Coppell, TX.

Key Responsibilities
• Ethical conduct and compliance
• Identify potential sources of variation in materials, processes, facilities, equipment, and products that may impact consistent performance or product quality
• Evaluate equipment and processes and identify potential critical parameters based upon possible impact on product quality attributes
• Prepare and perform qualification, requalification, and process validation protocols, analyze collected data against pre-determined criteria, and prepare final reports in compliance with relevant regulations, industry practices, and policies and procedures
• Perform and document field verification of equipment, instruments, and facilities as required by approved protocols
• Perform and/or review risk assessments for instruments, equipment, processes, and products
• Analyze data and information to determine whether processes, equipment, and products are within an appropriate state of control during qualification and validation as well as in assessing the need for requalification / revalidation on a periodic basis
• Prepare, document, and/or evaluate change controls to ensure that equipment, products, processes, and facilities remain in qualified, validated state
• Identify and investigate unusual or unexpected events, data, or sources of variation during the development and performance of qualifications/validations; assess and recommend disposition regarding the impact upon qualification or validation as applicable, and recommend appropriate corrective/preventive actions
• Ensure that work is performed in accordance with applicable regulations, industry guidelines and practices, approved procedures and cGMP
• Other responsibilities as assigned by department management
The estimated salary for this role is $120,000 - $160,000 per year.



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