Naveen Shekhawat
IT Project Manager
Jaipur
Summary
Hardworking Associate Director knowledgeable about business practices in the Life Sciences and Healthcare industry. Adept at supporting and enhancing operations with a decisive leadership style and strategic approach to decision making.
- Experienced: A technology evangelist and enthusiast with 15+ Years of experience in Project Management (PM), Computer System Validation (CSV) and consulting, 7+ years as CSV Lead and 7+ years as PM in GxP domain.
- Proficient: Proficient in CSV Consulting, Project Management, Technical delivery. Proficient in methodologies like Testing Life Cycle, Test Planning, Test Case Execution, Incident Management, Change Management.
- Coordinated and managed vendors to ensure a smooth transition from the application solution and design phase to the operations teams. Handled various projects of varying complexities for international Pharma giants in GxP domain simultaneously.
- Expert: Expertise in GAMP guidelines and good knowledge of GxP Analysis, Gap Assessment and 21 CFR Part 11 of US FDA in Validation along with EU Annex 11 and PMDA guidelines.
- Well-versed: Well versed with EMA, MHRA, PMDA guidelines on Pharmacovigilance, experienced in addressing external regulatory agency audits e.g. Health Canada, MHRA, PMDA etc. Well versed with Pharmacovigilance, Oracle Argus Safety, RIMS, Regulatory Affairs IT Project Management.
- Successful: Provided validation consulting solutions and worked on successful implementation projects for various pharmaceutical companies in past 15 years under various roles and responsibilities. Imparting internal trainings in CSV, GAMP 5 & GDP, GTP. Building teams under CSV and Application Support practice.
Overview
15
15
years of professional experience
Work History
Associate Director – PS&PV
Novartis India
2 2022
- Technical Design Expert (TDE) role is responsible for ensuring the successful implementation of projects and applications related to Patient Safety and Pharmacovigilance (PS&PV)
- Here are the key responsibilities: Conduct detailed system design reviews and obtain signoffs for PS&PV projects and applications
- This involves carefully examining the design and ensuring its alignment with the overall PS&PV application architecture and landscape
- Coordinated and managed vendors to ensure a smooth transition from the application solution and design phase to the operations teams
- Reviewed and approved project deliverables based on the Technical System Owner (TSO) role, ensuring compliance with established standards
- Effectively manage safety systems interdependencies, considering the impact on up-stream and down-stream applications during project implementations
- In addition to TDE, provide support to PS&PV by taking on Project Management responsibilities, overseeing projects of varied complexity and oversee their design, deployment, and delivery
- Here are the key responsibilities: Ensure timely delivery of projects, adhering to internal and regulatory guidelines while meeting the defined budget, timeline, and stakeholder requirements
- Direct project teams, including external resources, to maintain control over project progress, quality, and budget, ultimately achieving the desired business objectives
- Organized and led project-related meetings, documenting all actions, decisions, issues, risks, and acting as the primary point of contact for project escalations
- Facilitated a smooth transition to operations and planned and executed all activities associated with project releases
- Managed and updated project details such as cost plans, resource plans, risks, vendor payments, and change requests for ongoing projects
- Review and coordinate approval of Statements of Work (SOW) and change requests (CRs)
- Maintain system and project deliverables and provide support to the operations team during safety application audits
- Coordinate with business on demand management and approval.
Deputy General Manager - IT PM
Sun Pharmaceutical Industries Ltd.
02.2018 - 02.2022
- Managed IT programs for Pharmacovigilance and Regulatory Affairs
- Oversaw Drug Safety and Regulatory Affairs application portfolio management
- Handled complete project lifecycle and post-launch support
- Ensured end-to-end validation of GxP applications in line with QMS standards
- Maintained GxP Applications' validated state through change management
- Conducted Vendor Evaluation, Budget Assessment, Business Case Development, RFPs, RFIs, and SOWs
- Provided ongoing end user support for drug safety and regulatory affairs applications
- Coordinated regulatory audit responses from an IT standpoint
- Worked with both internal and external parties to ensure project progression
- Designed and implemented Vendor/CRO Oversight processes.
Principal Consultant –Validation
Foresight Group International now IQVIA
01.2017 - 02.2018
- Comprehending the client's Quality Management System (QMS) methods and devising a corresponding validation plan
- Drafting key Software Development Life Cycle (SDLC) documents such as the Validation Plan and Requirement Specification in collaboration with the client
- Participating in workshops to extract essential outcomes/requirements and evaluating their effect on the broader validation approach
- Coordinating with international teams regarding validation necessities
- Creating critical documents like the Validation Plan, User Functional Requirements Specification (UFRS), Test Protocols, and Summary Reports
- Overseeing the internal team in the creation and preliminary testing of the test scripts
- Taking an active role in the configuration stream to ensure that the validation strategies align with the project's overall goals
- Educating staff on Computer System Validation (CSV) processes and Good Automated Manufacturing Practice (GAMP) standards
- Supporting Project Managers in the conduct of the project by engaging in and leading status meetings and workshops
- Overseeing project planning and resource allocation
- Contributed to the successful execution of CSV projects for 16 premier pharmaceutical firms
- Proven expertise in managing several tasks concurrently
- Integral part of the team that deployed the QMS for Cloud applications.
Assistant System Engineer
TCS Ltd
02.2011 - 10.2011
- Engaged in Computer System Validation (CSV) life cycle processes, taking on responsibilities such as Tester, reviewer, and approver for validation tasks
- Performed internal audits related to Part 11 and HIPAA regulations
- Provided training to project team members.
IT Support Consultant – I.T. Systems (Computer Validation)
Ranbaxy Labs Ltd.
12.2008 - 02.2011
- Contributing to the entire validation cycle of several projects as a member of the IT team, fulfilling roles that included authoring/executing validation documents and representing IT Quality Assurance in IT development and implementation projects
- Serving as an IT representative during CAPA (Corrective and Preventive Action) processes as needed
- Collaborating with the IT team on software and hardware installation and effectuating adjustments as necessary
- Overseeing internal GxP-compliant applications from the IT standpoint by providing support, executing SQL queries, and creating software modules.
Education
B.E. in Computer Science Engineering (2004-2008) from Institute of Engineering and Technology, Alwar, Rajasthan, affiliated to University of Rajasthan, Jaipur. -
Bachelor of Engineering - Computer Science
IET Alwar, University of Rajasthan
Alwar 04.2001 -
Skills
Implementing and managing applications in GxP environments, GxP Applications implementation in public Cloud Environments like AWS, employing Agile methodologies in GxP Environments
Personal Information
- Father's Name: Mr. Madan Singh Shekhawat
- Date of Birth: 02/20/86
Languages
English, Hindi
Timeline
Deputy General Manager - IT PM
Sun Pharmaceutical Industries Ltd.
02.2018 - 02.2022
Principal Consultant –Validation
Foresight Group International now IQVIA
01.2017 - 02.2018
Assistant System Engineer
TCS Ltd
02.2011 - 10.2011
IT Support Consultant – I.T. Systems (Computer Validation)
Ranbaxy Labs Ltd.
12.2008 - 02.2011
Bachelor of Engineering - Computer Science
IET Alwar, University of Rajasthan
04.2001 -
Associate Director – PS&PV
Novartis India
2 2022
B.E. in Computer Science Engineering (2004-2008) from Institute of Engineering and Technology, Alwar, Rajasthan, affiliated to University of Rajasthan, Jaipur. -
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