Product Lifecycle Management Analyst Ii T500-**

Scope of Responsibility:

• Evaluates Change scope to determine feasibility and impacted Products, Projects
• Applies problem-solving skills to analyze scope of Change and the underlying business dataset (e.G., Items, Documents, Bill of Materials, Facilities, Instruments/Equipment, EH&S)
• Packages Change scope in the form of Change Request and Change Orders – in the most efficient manner, in order to bring efficiencies to scale
• Links Changes to critical dataset e.G., Projects, Products and other relevant Changes e.G., Parent Changes
• Prioritizes processing Changes in full alignment with the defined Service Level and expected metrics (e.G., turnaround time and quality service level)
• Performs thorough data analysis in light of the Change scope, in order to achieve higher accuracy level of impacted items. Scope includes, but not limited to Item and Document search – by key attributes, and descriptions both within PLM and PLM ecosystem e.G., SAP, Camstar, LIMS etc.
• Verifies accuracy and completeness of Changes packages by other Change Originators – where necessary, in full conformance with the underlying procedures, work instructions or job aids.
• Builds implementation plan – as per the outcome of Change Request Assessment
• Performs Document Redlines – in full conformance with Good Documentation Practice (GDP) principles and Change scope. Set effectivity dates once the Change is approved.
• Performs data quality review while processing Change workflows. Review risk towards data integrity, check for data completeness and accuracy while advancing PLM workflows through lifecycle stages

Experience Required:

• 2-4 years of prior professional experience in the PLM space of a MedTech company with working knowledge of Enterprise Change Management, Master Data Management and Enterprise Document Control
• Well versed with basic GMP, GDP, regulatory and compliance requirements of a MedTech company e.G., 21 CFR 820 (Quality System Regulation), 21 CFR Part 11 (Electronic Records and Electronic Signatures) and 21 CFR Part 809 (In-Vitro Diagnostic Products)
• Prior experience of Data Stewards role processing Item and Document Master Data in a controlled setup is preferred
• Prior experience of Document Control or Document Data Steward for a Life Science company is preferred