This document contains the resume of Sarada Gudipati, who has 12 years of experience in IT compliance, quality assurance, and computer system validations in the pharmaceutical and biotechnology industries. She has extensive experience implementing quality methodologies and ensuring compliance with FDA regulations. Her skills include quality assurance, compliance, validation, and project management. She is currently an IQOQ Lead at Johnson & Johnson, where she previously served as a Compliance Lead, and has experience reviewing documentation and leading qualification activities.

1. Sarada Gudipati
Cell: 7328295841 Email:sarumurali@yahoo.com
Professional Summary
 Twelve years of experience in IT including Eleven years of experience in Compliance,
Quality Assurance, Computer system Validations, 21 CFR part 11 Compliance in
Pharmaceutical and Bio-technological companies.
 Experience in Laboratory systems, Business applications and infrastructure qualification.
 Extensive working knowledge on SDLC, CDS and Validation Life Cycle.
 Extensive experience in implementing QA methodologies (spiral, iterative, RAD) and
Software Engineering Process, Test Plans, Test cases, Test Scenarios, and
Documentation.
 Excellent hands on experience and knowledge of Food and Drug Administration (FDA)
regulations (particularly 21 CFR Part 11/ 210/ 211/ 820) qualification-testing protocols
(IQ, PQ, OQ).
 Experience in GxPs (GMP, GCP, GLP). Validation process and QA Strategies. Strong
experience in Validation Master Test Plan (VMP), Validation Life Cycle (VLC), SOPs,
Validation Summary Reports, Discrepancy Investigation Reports.
 Hands on Experience as a Quality Reviewer, reviewing qualification documents for
various applications and systems.
 Hands on experience on Corrective And Preventative Action(CAPA) from investigations
to closure.
 Good mentoring skills, analytical skills, presentation skills with strong communication
skills.
 Diligent worker, self-starter and consistent performer.
 Adaptable to work as a team member and also independently.
 Good Negotiator dealing with different teams and reaching a mutual satisfactory
agreement to get a win-win situation.
 Flexible to changing situations.
Skills
Quality Self-motivated
Compliance Powerful negotiator
FDA regulations Process implementation
Process excellence Team leadership
Computer systems Validation Staff development
Infrastructure Qualification Strong verbal communication
IT Quality Project management
Application Validation Self-motivated
SAP Powerful negotiator

2. Sarada Gudipati
Cell: 7328295841 Email:sarumurali@yahoo.com
Work History
Information technology Services (ITS) JnJ World Head Quarters Oct ’13 – Till Date
IQOQ Lead – Employee
 Identified gap in current process and presented it to the management.
 Made that as a green belt project to look at the root causes for the problem.
 Met with multiple leaders and stakeholders to show the reasons and possible solutions for
these reasons.
 Negotiated jointly with different teams and reached to a mutual satisfactory agreement to
get a win-win situation.
 Researched on my ideas to make sure that any claims that I made can be verified.
 Presented organization the problem, root cause and associated logical solutions.
 Delegated tasks to people with appropriate skill set.
 As a Quality and Compliance Manager for an external Vendor(HCL) provided leadership
and oversight of infrastructure qualification compliance activities and provide day to day
guidance to IT Q&C infrastructure qualification, operations and engineering teams.
 As a Global Process owner took responsibility for the implementation and oversight of
infrastructure qualification program for all devices being deployed by IT Shared Services
and ensuring that the qualification process meets all applicable internal and external
regulatory requirements.
 As a creator/initiator of a program called Lunch with Leaders took ownership of various
activities and supported talent acquisition, performance and development in a way that
maximized the performance and development of self and others.
Information technology Services (ITS) JnJ World Head Quarters Aug ’04 – Oct ’13
Compliance Lead – Contractor
 Responsible for the design and maintenance of infrastructure qualification process,
including input into the associated SDLC processes.

3. Sarada Gudipati
Cell: 7328295841 Email:sarumurali@yahoo.com
 Provide oversight for resource demand, allocation, and execution of IQ/OQ activities in
accordance with SLAs and metric targets.
 Reviewed, Revised and Edited SOPs, IQ/OQ/PQ Protocols, and assisted in the
development, support of all associated documentation and Standard Operating Procedures
and also to ensure compliance with 21CFR Part 11 regulations.
 Conducted routine internal inspections of regulated systems (GLP, and GCP) to assure
validation procedures have been followed in compliance with company, divisional and
department policies
 Prepared documentation for all aspects of the computer systems validation lifecycle
(Validation Plan, Installation Qualification Specification, Operation Qualification
Specification) in accordance with FDA regulations.
 Provide Quality & Compliance Infrastructure Qualification guidance, review and
approval for complex infrastructure projects
 Reviewed the entire SDLC including IQ/OQ documentation and ensured that the testing
and documentation is done as per the site procedures.
 Reviewed Server IQ/OQ Protocols, and assisted in the development, support of all
associated documentation along with Standard Operating Procedures to ensure they are
compliant in conjunction with 21CFR Part 11 regulations.
Education
Bachelors in Computer Science
Andhra Open University 1998
Accomplishments
 Lunch with Leaders Initiator and Creator
 Introduced, Initiated and Built new process to business: Renaming CIs process, BCP process for
completing IQOQs, Retrospective to Migration part of Retro reduction project, Acquired
company process guidelines.
Certificates
 GreenBelt
 ITIL