REMOTE OPPORTUNITY!!!!!!!!
Client: Technology GCC for Global Biotech Company
• Bachelor’s degree with over 10 years of experience in designing and developing solutions in Trackwise.
• Experience working in a GMP environment, 7+ years in an IT Systems Role.
• Expert knowledge of GMP Quality Management to include CAPA/Deviation, Lab Exception, Product Complaint, Audit, and Supplier Management.
• SDLC/GAMP, Business Analysis, and Enterprise Systems Management.
• General knowledge of GxP Quality Processes and Systems (GMP, GLP, GCP, GVP, GDP)
• Demonstrated experience leading teams in the implementation of Trackwise and QMS solutions, ensuring alignment with business objectives and compliance requirements.
• Comprehensive understanding of Quality Management processes, regulatory compliance, and industry standards.
• Certification in Trackwise or Equivalent Experience is required.
• Strong leadership skills with the ability to manage and mentor a team of analysts and developers.
• In-depth knowledge of Quality Management business processes within a regulated environment, including CAPA/Deviation, Lab Exception, Audit, Product Complaints, and Supplier Management
• Extensive knowledge of Trackwise and other QMS modules, with additional familiarity with ERP, SCM, and PLM systems.
• Exceptional oral and written communication skills, with the ability to conduct effective presentations, facilitate workshops, and negotiate with stakeholders.
• Excellent organizational and prioritization skills, capable of managing multiple projects and tasks in a dynamic environment.
• Proven ability to handle multiple responsibilities, including system configuration, coding, system testing, end-to-end testing, and production support.
• Experience in all phases of the project life cycle from analysis and design to implementation and testing, with a focus on business process improvement and optimization.
• Strong analytical and problem-solving skills, with the ability to translate business requirements into technical solutions.
• Strong team player with excellent collaboration skills, fostering a positive team environment.
• Strong Knowledge of SDLC, GAMP, and Computer Systems Validation in a GxP Environment
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