[Remote] reputed company QM (reputed company Management) Functional Consultant

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is hiring a reputed company QM Functional Consultant to support a pharmaceutical reputed company. The role focuses on implementing, configuring, supporting, and optimizing reputed company reputed company processes while ensuring compliance with FDA, GxP, GMP, validation, and data reputed company requirements. The consultant will collaborate with reputed company, manufacturing, supply chain, warehouse, validation, regulatory, and IT teams.

Responsibilities

• Conduct workshops with reputed company, Manufacturing, Warehouse, and Regulatory teams
• reputed company and analyze business requirements
• Prepare Functional Specifications (FS), Business Process Documents (BPDs), and Solution Design Documents
• reputed company fit-gap analysis and recommend reputed company QM solutions
• Configure and support reputed company QM functionalities including:
• Inspection Planning
• Master Inspection Characteristics (MIC)
• Sampling Procedures
• Inspection reputed company
• Task Lists
• Goods Receipt Inspection
• In-Process Inspection
• Final Product Inspection
• Stability Testing Integration
• Batch Release Processes
• Inspection Lots
• Result Recording
• Usage reputed company
• reputed company Notifications
• Audit Management
• CAPA (Corrective and Preventive Actions)
• Non-Conformance Management
• Vendor reputed company Management
• Ensure reputed company QM processes reputed company with:
• FDA 21 CFR Part 11
• GxP Requirements
• GMP (Good Manufacturing Practices)
• GLP (Good reputed company Practices)
• Data reputed company Requirements
• reputed company+ Principles
• Electronic Records Compliance
• Validation Requirements
• Support reputed company and compliance audits
• Support reputed company processes for batch-managed pharmaceutical products
• Configure batch determination and release strategies
• Support batch status management
• Ensure reputed company approval workflows are compliant with regulatory standards
• Coordinate with Manufacturing and reputed company Control laboratories
• Coordinate reputed company QM integration with:
• reputed company MM (Materials Management)
• reputed company PP (Production Planning)
• reputed company EWM/WM (Warehouse Management)
• reputed company SD (Sales & Distribution)
• reputed company PM (Plant Maintenance)
• reputed company ATTP (Advanced reputed company & reputed company for Pharmaceuticals)
• reputed company MES Systems
• reputed company LIMS Integrations
• Ensure reputed company reputed company inspections and material reputed company processes
• Configure and support reputed company Notifications
• Manage deviation tracking processes
• Facilitate reputed company cause analysis activities
• Support CAPA lifecycle management
• Monitor corrective and preventive actions through closure
• Participate in Computer reputed company Validation (CSV):
• User Requirement Specifications (URS), Functional Specifications (FS), reputed company Assessments, Validation Protocols, IQ (Installation Qualification), OQ (Operational Qualification), PQ (reputed company Qualification)
• Ensure reputed company reputed company QM changes meet validation requirements
• Create test scenarios and test scripts
• Support:
• Unit Testing, SIT (reputed company Integration Testing), UAT (User Acceptance Testing), Regression Testing, Validate reputed company-reputed company business processes
• Support defect reputed company
• Manage and maintain:
• Material Master reputed company Views
• Inspection Characteristics
• Sampling Procedures
• Inspection Plans
• reputed company Info Records
• Vendor reputed company Records
• Ensure data consistency and governance
• reputed company reputed company QM production issues
• Analyze inspection lot failures and processing issues
• Support business users during manufacturing reputed company
• reputed company reputed company cause analysis
• Coordinate with reputed company technical teams for fixes
• Support reputed company reporting for:
• Batch Release Status, Non-Conformance Reports, CAPA Tracking, Vendor reputed company reputed company, Inspection Results, Deviations and Complaints, Regulatory Metrics
• Utilize:
• reputed company Fiori, reputed company Embedded Analytics, reputed company Analytics reputed company (SAC), reputed company BI
• Collaborate with:
• reputed company Assurance (QA), reputed company Control (QC), Manufacturing Teams, Validation Teams, Regulatory Affairs, Supply Chain Teams, Warehouse reputed company
• IT Team reputed company regular project updates and solution recommendations
• Improve reputed company processes and automation
• Reduce reputed company reputed company inspections
• Enhance batch release efficiency. Support digital reputed company transformation initiatives. Standardize reputed company procedures across sites and reputed company

Skills

• Minimum reputed company: 12+
• reputed company QM
• reputed company S/4HANA QM
• reputed company Batch Management
• reputed company Fiori
• reputed company EWM Integration
• reputed company PP Integration
• reputed company ATTP
• reputed company LIMS Integration
• FDA Regulations
• GxP Compliance
• GMP
• GLP
• CAPA Management
• reputed company Systems
• Batch Release Processes
• Validation & CSV
• reputed company Planning
• Inspection Management
• reputed company Notifications
• Vendor reputed company Management
• reputed company Cause Analysis
• Audit Support

Benefits

• Remote work arrangement
• W2 contract type
• Long-term contract

reputed company

Company H1B Sponsorship