This document provides a summary of Robin Peterson's professional experience and qualifications. Robin has over 6 years of experience as a Validation Analyst in the life sciences industry. Robin has extensive experience with validation lifecycles, interacting with clients to define requirements, and generating validation documentation. Robin has worked at several pharmaceutical companies, leading validation projects and ensuring compliance with FDA regulations.

1. Robin Peterson
petersonval478@gmail.com
908-336-3512
Professional Summary:
 Over 6 Year’s years of extensive experience as Validation Analyst in life sciences industry.
 Have experience of end to end validation life cycle.
 Experience includes interacting with clients in gathering the requirements, planning the system design,
developing test strategy, creating test protocols and generating validation documents for various IT
systems.
 Extensive knowledge in Food and Drug Administration (FDA) regulations, 21 CFR Part 11 (Electronic
Records and Electronic Signatures), Part 210 (cGMP in manufacturing, processing, packaging and
holding of goods), Part 211 (cGMP for Finished Pharmaceuticals), and Part 820 (Quality System
Regulation).
 Experience in cGxP environments like cGMP, cGLP, and cGCP and developing IQ, OQ, PQ, VMP,
URS, FRS, DS, TM, VSR and SOPs following Change Control procedures and Good Documentation
Practices (GDP).
 Experience in authoring and reviewing Test Scripts against requirements and design documents
following quality and compliance regulations.
 Involved in various full cycle ITsystem implementations. Knowledge of life sciencesindustry practices
and regulatory expectations asthey relate to validation, remediation and qualification programs. Quality
and detail oriented, ability to interact with all levels of the organization and influence decision making.
 Functionality Testing, Integration Testing, System Testing and User Acceptance Testing.
 Used HP Quality Center for test scripts creation, execution and tracking defects.
 Participation in 21 CFR Part 11and GxP compliance assessments.
 Strong knowledge and understanding of GAMP5 and regulatory compliance issues along with current
pharmaceutical industry standards.
 Extensive experience in conducting Computer System Validation risk assessment.
 Deep understanding of software testing and experience with both manual and automated testing
techniques.
 Experienced in developing Requirement Traceability Matrix (RTM) and maintaining the Version
control.
 Excellent communication and documentation skills in the field of technical writing.
Professional Experience:
TEVA Pharmaceuticals, NJ Aug 2015 – Till Date
Validation Engineer.
 Responsible for preparing process validation/verification protocol and report for tablet
manufacturing process
 Involving in technology transfer from R&D to manufacturing by validating the manufacturing
process and providing the BMR for commercial production to manufacturing by change control
system using Trackwise software
 Involving in cleaning validation activities
 Resolving any issues associated with process through incident investigation system.
 Initiate and write Protocol Deviation, determination of the cause and suggestion of the corrective
action to close deviation.
 Communicating with cross functional team for validation activities and plan
 Assisting investigation related to OOS, non-compliance and product complaint by using

2. investigation tools such as CAPA, FMEA, root cause analysis.
 Perform the statistical evaluation (Control Charts, Process Capability index) of the data generated
using Minitab 16 statistical software.
 Work in controlled cGMP environment and within the compliance of various QA systems
(Document Control CAPA, Investigation, Change control)
 Responsible for reviewing specification, drawing documents to ensure validation protocol are in
line with manufacturer's specification
Purdue Pharma L.P - Stamford, CT Apr 2013 – July2015
Validation Engineer.
 Followed SOPs and Validation Plan throughout validation process and provided inputs.
 Analyzed User and Functional Requirements Specification Documents, Design documents for
test script preparation.
 Involved in preparing Test Plan and Operational Qualification Protocol (OQ). Developed IQ, OQ,
PQ Test Scripts and Scenarios based on FRS and System Design Document. Executed the
developed and existing scripts for both dry run and formal testing.
 Performed pre and post review of test scripts against FRS in HPQC.
 Identified defects from test execution and logged, tracked and managed defects in HPQC.
 Developed Validation Summary Report, Incident Reports, Traceability Matrix and Change
Control documents. Performed Gap Analysis and Data validation.
 Developed UAT Test Scripts manually and helped users in executing them. Documented the
defects identified. Also involved in defect tracking and management.
 Responsible for ensuring that all documentation and procedures comply with the FDA 21 CFR
Part 11 Regulations. Involved in preparing 21 CFR Part 11 Risk Assessment and Overall Risk
Assessment document.
 Reviewed validation deliverables and change control documents.
 Extensive interaction with 3rd party vendor, IT, Users,SME, Business Owners,and QA
departments to develop and maintain validation procedures and get the validation documents
reviewed and approved. Also reviewed executed test Scripts and scenarios.
 Responsible for creation of Project Checklist / Task Plan, Conducting Weekly Review meetings
and sending Minutes of Meeting Report to all the responsible persons.
Eisai Pharmaceuticals, NJ Jan 2012 – Mar 2013
Validation Engineer
 Worked with team members to understand the requirements and implementation of the application.
 Involved in validation of TrackWise application for highest level of quality control to reduce costs
and maintain margins.
 Followed SOPs and Validation Plan in carrying out different validation activities.
 Analyzed Systems Requirements Specification (SRS) and System Design Specification (SDS),
developed Test Plan, OQ, Test Scripts and scenarios manually.
 Reviewed SRS, URS, SDS, Test plan, pre and post executed test scripts, Validation Summary
report.
 Involved in reviewing Traceability Matrix to ensure that all requirements are tested.
 Reviewed pre and post executed test Scripts developed and executed by other testers against SRS
to ensure they meet quality and compliance regulations.
 Provided guidance to other testers in handling test script errors and creating defect reports
according to company guidelines.
 Executed OQ Test Scripts and Scenarios manually both for dry run and formal testing.

3.  Bugs identified were documented by creating an Incident Report manually. Involved in defect
tracking and management through Bug Tracker (Documentum eRoom).
 Reviewed GxP Criticality Assessment Document,Change Control Document, 21 CFR Part11 risk
assessment,Deviation Reports and Validation Summary Report. Reviewed IQ, OQ,PQ protocols,
Test Plans, Change requests and manuals.
 Reviewed UAT Scripts manually based on the Business Requirements.
 Performed Black box, Functional, Regression and UAT testing when necessary.
 Performed QA review of Validation deliverables developed by third party vendor.
 Reviewed different validation deliverables and Change Control documents.
 Prepared final Validation binders for paper documents.
 Attended weekly meetings with Validation team and also interacted with Developers, Business
Analyst, SME, UsersandInformation Systems departments to help them resolve the bugs identified
during execution. Also reviewed other validation documents.
Quagen Pharmaceuticals, NJ May 2010 – Dec 2011
Validation Analyst
 Worked with Validation Manager in defining the boundaries of validation activities in Planning.
 Created and reviewed Operation Qualification (OQ) and UserAcceptance Testing (UAT) test cases
for different modules of LIMS based on the User and Functional Requirement specifications
(UFRS).
 Developed, reviewed and executed the system related OQ and PQ Protocols.
 Validated Login screens and access profiles in LIMS based on the user requirements for User
Interface (UI) testing.
 Reviewed, coordinated and maintained CSV Change Controls.
 Translated technical information into clear, concise instructions that are standardized easily
followed and understood.
 Drafted new SOP's and trained all users on the systems, implications and impact of 21 CFR Part 11
compliant data systems on day-to-day functions.
 Wrote and executed test scripts based on the test plan and in accordance with Good Documentation
Practices (GDP).
 Performed FMEA risk assessment against the requirements document.
 Documented test execution report and prepared Requirement Traceability Matrix (RTM).
 Performed Gap Analysis of the system taking into account the User Requirements and System
Requirements.
 Responsible for CAPA management and corresponding change control procedures.
 Involved in auditing the application for 21 CFR Part11 compliance related to Electronic Signatures
and Electronic Records for a closed System.
Education:
 Masters in Industrial Pharmacy, Stevens Institute of Technology.