SUMMARY

• Over 6 years of experience in Validation/QA/QC and testing of process and applications in Pharmaceutical Industry.
• Extensive experience in preparation of all system qualification documentation, Project Validation Plans/Reports, IQ/OQ/PQ Protocols and Reports. Also provided training to team members in preparation of Protocols.
• Developed functionality Test Scripts to test the system functionality based on approved system requirements.
• Excellent knowledge of testing methodologies, strategies and Software Development Life Cycle (SDLC).
• Involved in Change Control and developed Change Notification Form (CNF).
• Thorough knowledge of system integration for process automation with compliance to CFR Title 21 Part 11 of the FDA regulations.
• Good Understanding of 21 CFR part (11, 50, 56, 210, 211, 820) and other FDA rules and Regulations.
• Excellent Understanding of cGXP (cGMP, cGLP, cGCP).
• Extensive experience in performing 21 CFR Part 11 Gap Analysis, Risk Analysis and developing Remediation Plans.
• Develop Test Plan, Test case Specification and Test Release Reports for all phases of testing i.e. unit testing, Integration testing IQ, OQ and PQ.
• Maintained Requirements Traceability Matrix (RTM) and exposure to quality control.
• Expertise in calibration and validation of lab equipment like Incubators, Ovens, HPLC and UV spectrophotometer.
• Good knowledge of Cleaning Validation like establishing Cleaning Procedure, Analytical Methods and Validation protocols and reports.
• Knowledge of Clean - in-Place, Sterilization-in-Place (SIP), Drying-in-Place (DIP).
• Experience in Corrective Action Prevention Action (CAPA), change control process, Training, investigations, and document management process.
• Performed various boundary tests as well as data validation to ensure record retrieval and search engine tests.
• Experience in executing software validation protocols (installation and operational qualifications.)
• Excellent knowledge of 21 CFR Part 11, GLP, cGMP and GAMP guidelines.
• Demonstrated capabilities to quickly gain a detailed understanding of a process in order to optimize efficiencies, reduce cost, and improve quality.

TECHNICAL SKILLS

Validation: 21 CFR Part 11, cGXP (cGMP, cGDP, cGLP), GAMP, GCL GPV Quality System Regulation (QSR), Audit Trails, Standard Operating Procedures (SOP's), Gap Analysis and Remediation,ValidationPlan and Protocols, Configuration Management, RTM, Risk Analysis

Testing Tools: HP Quality Center/ALM, Quick Test Professional, Test Director

Operating Systems: Windows 2012/XP and UNIX

Business Tools: SQL, SAS, SPSS, Oracle EBS, ERP, SAP, CRM and EDMS platforms MS Office Suite 2010, MS Project and Visio

PROFESSIONAL EXPERIENCE

Confidential - Lincoln, RI

Sr Validation Engineer

Responsibilities:

• Reviewing new projects from regulatory standpoint. Ensuring part 11 assessment gets completed in the tool kit and review of all evidences and evaluations done before go live of projects.
• Support was from standpoint of ensuring validation deliverables meet SOP and quality standards, review and approval of the same.
• Ensuring requirement tracing. Pre and post approvals of test scripts in HP quality Centre.
• Completed 21 CFR Part 11, GxP and Functional Risk Assessment for the system.
• Developed Validation Plan to outline activities, deliverables and roles and responsibilities.
• Develop and verify Periodic Review plan, Back-up and Disaster Recovery plan and Change Control plan for post-deployment support.
• Attended requirements gathering sessions, reviewed System Design Specifications and System Baseline Configuration.
• Created Testing Documentation including Test Plan, Test Cases, Test Scripts, Requirements Traceability Matrix (RTM), Defect Report and Test Summary Report.
• Used Quality Management tools such as HPQC to manage requirements, test plan, test scripts and defects.
• Managed defects by ensuring that proper documentation and corrective actions have been implemented.
• Participated in Defects Resolution process by coordinating with Developer, Application Manager and SME.
• Reviewed Requirements Traceability Matrix to ensure that all the requirements are appropriately tested in designated test phases.
• Closely worked with business representatives to provide guidance on creation of User Acceptance Test (UAT) scripts during implementation.
• Review and approvals of execution of IQ, OQ and PQ Scripts.
• Summarized Validation activities, test results, and open issues in the Validation Summary Report.

Confidential - Miami, FL

Validation Engineer

Responsibilities:

• Prepared and maintained the Standard Operating Procedure (SOPs) and Validation Summary Report.
• Responsible for all Electronic Quality systems upgrades and Validation.
• Developed IQ/OQ/PQ test scripts for all Reporting components.
• Responsible for GAP Assessment for different electronic quality systems and fill the gaps to prepare for the FDA Audit.
• Wrote the Test Scripts and analyzed Test Scripts to check if it has covered the functionalities, which need to be in compliance with 21CFR Part 11 rules set by FDA.
• Responsible for design procedures, Manufacturing process, Electronic quality systems remediation plans, Engineering Evaluation and design Verification Testing.
• Conducted Risk Analysis meetings to analyze the risk involved in implementing the system in the existing business process and document Risk Assessments for gaps identified.
• Responsible for in writing and reviewing Standard Operating Procedures (SOPs), Work Instructions (WIs), Requirement Traceability Matrix (RTM) and Validation Summary Report (VSR)
• Preparing all the documents for FDA Audit.
• Reviewing Test scripts, Protocols for the Final Execution.
• Performing the Inventory for Document Management System.

Confidential - Melrose Park, IL

Validation Engineer

Responsibilities:

• Validation Engineer for an injectable drug aseptic pharmaceutical plant.
• Represents Technical Services in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
• Work with vendors during installation and startup of new equipment to validate equipment to specification.
• Lead, manage and execute qualification of small capital projects, and process improvement changes related to the manufacturing within the plant
• Present study results during audits (Regional, Client, or Food and Drug Administration, FDA) when necessary.
• Served as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention.
• Provide training of new equipment to production operators and assist in the generation of new standard operating procedures.
• Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
• Schedules and executes equipment re-qualification per Standard Operating Procedures (SOPs).
• Consistently perform work in ISO 100, ISO 10,000, and ISO 100,000 environments.
• Conducts and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA).

Confidential

Validation Engineer

Responsibilities:

• Reviewed & Documented Business User Requirements and Functional Requirements
• The project involved in performing the periodic reviews of the computer servers.
• Gathering all the documentation like the IQ/OQ/PQ, change controls, validation plans, summary reports for each server.
• Analysis of these documents along with system owners.
• Following a standard procedure of the company to check for compliance of these documents with the latest standards followed in the company.
• Same procedure followed for dealing with infrastructure compliance checking.
• Preparation of the final periodic review document.
• Interviewed Subject Matter Experts (SMEs) to gain insight into what should be included in documents
• Involved in calibration reporting of all equipment in the manufacturing department
• Investigation and introduction of new equipment for better Quality assurance.