SUMMARY

• 6+ years of Professional experience as a Validation Specialist in pharmaceutical environment with expertise in Computer system validation, process validation, cleaning validation, technical writing, QA testing in FDA regulated environment. Proven knowledge and experience to work in manufacturing, laboratory environment and quality systems regulated under FDA and ICH guidelines. Technical proficiency in R&D, QA/QC, process and cleaning validation
• Expertise in preparing technical documents for validation protocols including Validation Master Plan (VMP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Standard Operating Procedures (SOPs), Validation Summary Reports (VSR), Test summary report (TSR), Gap Analysis, Remediation plans, and Requirements Traceability Matrix (RTM).
• Professional experience in cGMP, GXP (GMP, GLP, GCP), 21 CFR Part 11, GAMP for Pharmaceutical/Biotech manufacturing
• Author, review, and approve protocols for qualification of systems to meet Validation and Part 11 requirements
• Extensive knowledge in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Specification (DS), process with experience in writing manual test cases for quality assurance.
• Experience working in cleaning, cleaning in place (CIP) sanitization and sterilization validation procedures for various pieces of equipment (Autoclaves, Chromatography, Spectrophotometers, Mixing Tanks, and Buffer Tanks).
• Extensive experience with Laboratory Information Management Systems (LIMS) and integration with equipments (HPLC, GC, FTIR, Spectrophotometer, pH/EC meter).
• Working knowledge of EDMS (Enterprise Document Management System), LIMS (Laboratory Information Management System), AERS (Adverse Event Reporting System), SQL & LABWARE, Change Control Management System (CCMS)
• Excellent knowledge of the components of Software Development Lifecycle (SDLC) and System Validation Lifecycle (SVLC).
• Experience working with Document Management System (DMS) like Documentum
• Excellent working knowledge of designing & implementation of all QA test strategy plans manually and automated test solutions for client/server and Web applications with HP test suite (Quality Center) and Manual Testing
• Referred 21CFRPart11 drug cGMP requirements including electronic records, electronic signatures, SOPs for Systems, system validation strategies and documentation
• Excellent experience as a Technical Writer/Documentation specialist working in FDA regulated environments
• Finalized the corrective action prevention action (CAPA) action plans with the vendor.
• Used SharePoint, e - Room, Documentum on a regular basis for document storage and retrieval.
• Strong communication, organizational and time management skills

TECHNICAL SKILLS

Validation: 21 CFR Part (11, 50, 56, 210, 211, 820)Validation Protocols (IQs, OQs, PQs), GXP (GCP, GMP, GLP), SOPsLIMS, Audit Trails, RTM, Gap Analysis, Remediation Plan

Testing Tools & Testing Skills: Quick Test Professional (QTP), Load Runner, Quality CenterBlack Box Testing, Regression Testing, Integration TestingFunctional Testing, User Acceptance Testing (UAT)

Database: Oracle, MS SQLSoftware Development Life CycleWaterfall, Agile, V Model, Spiral

Platforms: Windows OS, Mac OSX

PROFESSIONAL EXPERIENCE:

Confidential, Morgan Town, WV

Validation Specialist/Technical Writer

Responsibilities:

• Generated and reviewed standards CSV deliverables in compliance with 21CFR Part11.
• Reviewed and User Functional Requirements Specifications (UFRS).
• Developed IQ/OQ protocols as per user requirement and functional requirement specifications (URS and FRS).
• Revised Standard Operating Procedures (SOPs) to govern the development, change in management permissions, testing, release, deployment, training, document control in its Software Development Life Cycle (SDLC).
• Created flow charts in MS Visio.
• Assisted with Project Schedules and Task Lists.
• Used MS Project for scheduling and planning project activities.
• Created and maintained Requirement Traceability Matrix (RTM) for the application.
• Used Documentum for storing and maintaining the documents.
• Involved in preparation of Validation Strategy Document.
• Developed test plans, test strategies, test scripts for validation testing.
• Responsible for writing Validation Summary Report (VSR) to establish documented evidence that the system was validated.
• Responsible for reviewing of PQ test scripts. Involved in System Testing with testing team, used Quality center.
• Performed GAP analysis, Risk assessment and maintenance of hybrid systems, closed and open record systems.
• Developed training manuals for operating, auditing, and monitoring functions of the management system.

Confidential, Milwaukee, WI

Sr.QA Validation Engineer/Technical Writer

Responsibilities:

• Reviewed business requirements document and prepared detailed test plan
• Created, reviewed and executed test cases and test conditions
• Configured and validated LIMS to conform to regulations
• Involved in drafting training manual templates, project planning and document proofs
• Validated the application in accordance to FDA regulations and checked to ensure compliance with 21 CFR part 11 requirements
• Drafted and revised Standard Operating Procedures (SOP’s)
• Conducted GAP analysis and in turn prepared remediation plan
• Involved in User Acceptance Testing (UAT). Usability testing along with GUI testing and Regression Testing of the application.
• Executed Operational Qualifications (OQ’s) to make sure that the systems are capable of consistently operating between established limits and tolerances and started an issue log if not in accordance
• Initiated, maintained as well as updated the requirement traceability matrix
• Developed ways to enforce audit trails, data integrity and data security in analytical equipment
• Wrote VSR (Validation Summary Report) and Disaster Recovery Plan

Confidential, South San Francisco, CA

Analyst/QA

Responsibilities:

• The Scope of project was to validate Adverse Event Reporting System (AERS). AERS is used to report any adverse events during clinical trials. It is an effective tool for product safety, monitoring and compliance.
• Worked on AERS to capture all clinical trials.
• Responsible for developing standard document for validation deliverables like Validation Plan, Functional Requirement Specifications.
• Involved in documenting Vendor Assessment Report.
• Involved in developing Design Specifications (DS) document. Used MS Visio for pictorial representation of the Design Specifications.
• Responsible for writing training manual and SOP’s.
• Sharing knowledge for promoting best practices to be followed by project teams.
• Responsible for ensuring clinical medical device documents are in compliance with cGMP and GLP guidelines.
• Responsible for documenting IQ/OQ protocols.
• Created Requirements Traceability Matrix (RTM) to track the User and Functional Requirements.
• Developed test plans and test scripts for validation testing.
• Responsible for developing protocols for audit trail, time stamp and electronic signature for workflow of documents.
• Developed test cases and test scripts to perform regression testing.
• Involved with the development team to verify bug fixing and update bug report status using Test Director.
• Developing Validation Summary Report.

Purdue Pharma, Stanford, CT

Validation Analyst/Technical Writer

Responsibilities:

• Member of assessment team to study the 21 CFR Part 11 requirements.
• Wrote the Validation Assessment for the management to understand the importance of validation of core business functionality.
• Developed the Functional Specifications based on the Business User Requirements along with the Lead Developer.
• Coordinated with the Lead Developer to set up and build the prototype of the application.
• Review companywide policies and QA procedures.
• Created a Validation Plan based on the Project Scope, Testing Objectives and Testing Plan.
• Wrote documentation for all aspects of the computer systems validation lifecycle, in accordance with FDA regulations, particularly Part 11, including: Validation Plan and Protocol, Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification.
• Created the Test Plan for Protocol Execution and conducted Tester Training for the Test Script Execution.
• Configured the Specs and Analysis as per the SOP’s and the relevant Quality standards of the Business User.
• Set up the Exception Report Database and coordinated with the Lead Developer to resolve the bugs that was found.
• Maintained the Requirements Traceability Matrix (RTM).
• Drafted new SOPs and trained all users on the systems, implications and impact of 21CFR Part 11 compliant data systems on day-to-day functions.
• Peer review deliverables from project team members
• Set-up, assessed and analyzed the samples, and processed the data using various data reduction and Laboratory Information Management System.

Aurobindo Pharma

Validation Analyst/Process Engineer

Responsibilities:

• Developed and executed cleaning validation protocols for various pieces of equipment such as spectrophotometers, HPLC, autoclaves, bioreactors, centrifuges, incubators, buffer tanks and mixing tanks
• Performed validation on temperature distribution and penetration limits for autoclave, incubators
• Performed User and Business Requirements analysis to prepare Validation Master Plan and Validation Summary Report
• SIP/CIP System Validation - Author and execute IQ, OQ, and CV or PQ protocols
• Responsible for validating analytical methods and swab recovery study and cleaning validation protocols
• Checked the compliance of Electronic Records and Electronic Signatures in compliance with 21 CFR Part 11 regulations
• Updated and Maintained Required Traceability Matrix (RTM) as per the changing requirements
• Developed Validation Summary Report (VSR) to summarize the overall testing effort

Mahendra Satyam

Jr. Validation Analyst

Responsibilities:

• Interacted with off-shore team to gather and review user requirements and functional requirements.
• Involved in modeling of the software activity using Unified Modeling Language (UML)
• Participated in the preparation of Requirement Traceability matrix (RTM)
• Participated in meetings for performing and documenting Risk Assessment, Gap Analysis and creating Remediation Plan
• Created, maintained, organized, reviewed, and tracked documents and communication between India and US Team.
• Involved in Data Migration and developed User Acceptance Protocol to describe the specific objectives, procedures, data sets, test scenarios, expected results and acceptance criteria for the User Acceptance Testing (UAT) process.