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Role: Serialization Support Lead Analyst
Location:Indianapolis, IN / Remote
Duration: 12month+
Client : TCS

Job Description-
Experience of Process Automation Systems
Experience of Computer IT systems
Excellent computer and problem-solving skills
Familiarity with pharma packaging processes and packaging equipment custom software
Strong problem-solving and strong analytical skills are essential. Ability to troubleshoot issues and provide timely resolution.
Excellent analytical, organizational, team and project management skills
Experience and in-depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System Retirement. This includes deliverables such as Planning (Project Validation Plan or Validation Master Plan), User/Functional Requirements, Design Specifications, Design Qualification (DQ), Commissioning (FAT, SAT, Startup), Qualification Test Protocols (IQ/OQ/PQ), Process Validation (PV).
Excellent written/verbal communication skills
Excellent documentation skills
Strong understanding of software development lifecycle and maintenance plans
Experience of working in a support role/organization
Excellent troubleshooting skills
Experience in providing engineering support in 24/7 pharmaceutical manufacturing and packaging operations
Worked in direct support of and along with the maintenance staff to maintain both complex and simple systems used in packaging operations
Experience with Systems Management (disaster recovery, problem management, incident management, change management etc).
Understanding of Pharma Serialization.
Understanding of Packaging line hardware, PLC programming.
Experience of vision inspection systems used in packaging.
Familiarity with formal Change Management and Incident Management Processes.
Familiarity with Packaging solutions like Systech, and SAP ATTP and or TraceLink.