Product Lifecycle Management Systems Analyst

5 days ago

Bengaluru, Karnataka, India Leading-Biotechnology-Company Full time

Job Description:

The PLM Senior Analyst will be a crucial member of our team, responsible for managing the lifecycle of products from development to commercial operations. This role involves creating and submitting change control documents, managing their progress, and serving as a critical resource in the change management process.

Key Responsibilities:

  • Analyze and evaluate change scope to determine feasibility and impacted products, projects
  • Apply problem-solving skills to analyze scope of change and underlying business dataset (e.g., items, documents, bill of materials, facilities, instruments/equipment, EH&S)
  • Packaging change scope into efficient Change Requests and Change Orders to bring scale efficiencies
  • Link changes to critical datasets (e.g., specifications, projects, products) and relevant changes (e.g., parent changes)
  • Prioritize processing changes according to defined Service Level and expected metrics (e.g., turnaround time and quality service level)
  • Perform thorough data analysis for accuracy levels of impacted items, including item and document search by key attributes and descriptions within PLM and PLM ecosystem (e.g., SAP, Camstar, LIMS)
  • Verify accuracy and completeness of Change packages by other Change Originators, following procedures, work instructions, or job aids
  • Build implementation plans based on Change Request Assessment outcomes
  • Perform Document Redlines in compliance with Good Documentation Practice (GDP) principles and change scope, setting effectivity dates once approved
  • Review data quality while processing Change workflows, ensuring risk towards data integrity, checking for completeness and accuracy, and advancing PLM workflows through lifecycle stages

Experience Required:

  • 2-6 years of experience in the PLM space of a MedTech company, with working knowledge of Enterprise Change Management, Master Data Management, and Enterprise Document Control
  • Familiarity with basic GMP, GDP, regulatory, and compliance requirements of a MedTech company (e.g., 21 CFR 820, 21 CFR Part 11, 21 CFR Part 809)
  • Prior experience as a Data Steward, processing Item and Document Master Data in a controlled setup is preferred
  • Prior experience in Document Control or Document Data Steward for a Life Science company is preferred

Salary:

$120,000 - $150,000 per annum

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