Product Lifecycle Management Sr. Analyst

1 week ago

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


Job Description

PLM Senior Analyst 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 and managing them through closure, 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 and management of Change Requests and Change Orders and assures configuration and document changes include required information while resolving any issues that arise.

Scope of Responsibility:

  • Analyzes and 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/Equipments, 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., Specifications, 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:

  • 2-6 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

Core Job Summary

Core Job Summary

Position Summary:

Plans, schedules, coordinates and/or monitors final approval of products through the complete production cycle. May be responsible for the following activities: master scheduling, production planning/coordination, shop scheduling and dispatching, material requirements, planning systems, work-in-process tracking, material and labor variance controls, and manufacturing performance reporting.

Changes to individual responsibilities may occur due to business needs and other related duties may be assigned.

Scope of Responsibilities:

Applies core knowledge and understanding of area of specialization to provide solutions in creative and effective ways.

Assesses unusual circumstances and uses sophisticated analytical and problem-solving techniques to identify cause and suggest variations in approach.

Works on assignments of diverse scope where information is limited and problem solving requires adaptation of existing techniques.

Enhances internal and external working relationships and networks with senior partners within area of expertise.

Adapts style to differing audiences and often advises others on difficult matters that require persuasion.

Work is done independently and is reviewed at critical points.

Uses evaluation, judgment, and interpretation to select best course of action.

Experience/Education:

Typically requires a minimum of 5 years of related experience with a Bachelors degree; or 3 years and a Masters degree; or a PhD without experience; or equivalent work experience.

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