Serialization and Traceability Consultant - Remote

SERIALIZATION AND TRACEABILITY CONSULTANT - REMOTE

(AUTOMATED PROCESS EQUIPMENT)

SUMMARY:

• 100% Remote
• You will design and implement effective business processes to meet client requirements for the implementation of a global serialization and track and trace program
• Work closely with serialization team and internal business counterparts to ensure serialization solution meets regulatory timelines and deliverables

RESPONSIBILITIES:

• Lead the design and implementation of effective business processes with business users for the implementation of a pharmaceutical serialization and track & trace strategy
• Full scope business process integration with SAP ATTP and related systems
• Work closely with global supply chain team and internal business counterparts to develop business process requirements
• Develop technical specifications which meet the needs of the business and address project requirements
• Provide translation of business process requirements to use cases / user requirements
• Revise/ develop standard operating procedures & policies (SOP) as required per change implementations
• Develop OQ, IQ, PQ scripts

REQUIREMENTS:

• Experience integrating the serialization process into the manufacturing process, including master data, ERP and distribution enhancements
• Global regulatory compliance expertise (US/DSCSA, EU/FMD) and familiarity with RFID and 2D serialization methods
• Strong business analysis, technology and data management experience to help design future state business models and processes
• Experience working cross-functionally to ensure interdependencies and milestones are properly integrated into the project plans
• Experience collaborating with business partners and IT to develop User Acceptance Test scenarios to test requirements as outlined in the URS / business use cases
• Experience developing GMP related documents and protocols, including process maps, URS, FRS/DS, test specs, IQ, OQ, Integrated OQ & PQ, relevant summary reports and change controls

Salary Range: $85,000 - $115,000  Salary range is an estimate of pay for project-based employment. Range varies based on knowledge and experience.