PLM Analyst

2 weeks ago

Bengaluru, Karnataka, India Illumina Full time
Job Description

- We are seeking a PLM Analyst to be part of our talented team in Bangalore. This position will be an integral part of running core operations for the Product Lifecycle of a dynamic, fast paced organization for both new product development and on market commercial operations. The person in this role is responsible for creating and submitting change control, while serving as a critical resource in the change management process from inception through end-of-life for Illumina products. Maintains product and process configurations in PLM and SAP ERP. Supports cross-functional teams on the creation of Change Requests and Change Orders and assures configuration and document changes include required information while resolving any issues that arise.

Scope of Responsibility:

- Applies problem-solving skills to analyze scope of Change and the underlying business dataset (e.g., Items, Documents, Bill of Materials, Facilities, 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
- 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.
- 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:

- 3-5 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, 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

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