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Rajiv Harpalani

Rajiv Harpalani

IT Manager (Compliance & Validation Services)

AbbVie

Greater Chicago Area, us

- Insightful, results-driven IT professional with over 16+ years of notable success leading a broad range of Compliance, Security and Computer System Validation initiatives in the pharmaceutical industry. - Excellent understanding and experience in all phases of SDLC, CSV processes, industry regulations and standards, e.g., ...

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AbbVie

IT Manager (Compliance & Validation Services)

Responsible for managing a team of 6 Fulltime employees and 50+ Onsite and Offshore Validation/Testing resources.

Collaborates with all technology groups, lines of business, and corporate functional areas to define, gather and analyze metrics. Provides targeted reporting to all levels of IT and Business management.

Lead the IT Validation & Compliance team across multiple GxP and Non-GxP projects/applications. Provide guidance in the development and delivery of compliant IT systems.

Supervise and provide guidance to the staff (Validation Leads and Analysts) in the implementation of testing strategies and/or IT Compliance practices for the organization.

Perform resource planning and allocation across multiple projects/client areas for IT Validation & Compliance activities.

Oversees and manages all ongoing activities related to the development and implementation of GxP/CSV and compliance related aspects in the IT and QA policies & procedures.

Develop risk- based validation strategies for several large, medium, and small- sized projects including documenting, facilitating, reporting, monitoring, identifying issues, timely resolution and communication.

Identify, propose, initiate, and lead significant improvement programs related to data integrity, IT Security and compliance processes and practices.

Responsible for compliance with applicable Corporate and Divisional (IT and QA) Policies and procedures and serve as a source of information on the IT compliance needs and regulatory environment.

Maintain expertise, security & compliance trends through training, internal assessments, team collaborations in order to mitigate potential IT security exposures.

Skillful in creating and reviewing Validation deliverable such as Validation Change Requests, Validation Plan, Risk Assessment, Migration and Decommissioning Plans, IQ,OQ,PQ or Validation Testing – Results Review Reports and System Certification Summary.