SUMMARY

• 7 years of experience in the field of computer system validation in pharmaceutical and medical device industry.
• Special skills in validating reports, documenting validation protocols, LIMS and AERS as per FDA regulations and company standards.
• Profound knowledge related to pharmaceutical regulation like US FDA: 21 CFR part 11, 21 CFR part 58, 21 CFR part 210, 21 CFR part 211 and 21 CFR part 820
• Highly proficient with all the phases of SDLC (System Development Life Cycle) process, validation methodologies and concepts of qualification protocols (IQ/OQ/PQ)
• Proficient in maintaining and working with advance software tools like LIMS (laboratory information management system) and AERS (Adverse Event Reporting System)
• Experience in developing SDLC deliverables like User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS), Validation plan, Requirements Traceability Matrix and Validation Summary Report
• Knowledge of different models of SDLC with proficiency in V model, Agile, and Waterfall model
• Highly experienced in Technical Writing and Report Generation
• Expertise knowledge in handling GLP, GCP, cGMP, GAMP, GDP and ICH guidelines, especially 21 CFR part 11
• Very good overview of specifications, methods and change controls used in pharmaceutical manufacturing environments
• Experience in preparing Test strategies, Test plans, Test scripts and Test reports, analyzing bugs and interaction with development team for fixing the defects
• Good understanding and Practical knowledge on GAMP 4 & 5 regulations
• Knowledge and experience with testing tool: HP ALM
• Profound knowledge in MS office tools such as MS word, PowerPoint, MS Excel
• Excellent organizational, interpersonal, written and oral communication skills
• Proficient in working individually and as a part of a team

TECHNICAL SKILLS

Validation: 21 CFR Parts (11, 58, 210, 211, 820), GxP, VMP, VSR, IQ/OQ/PQ, SOP, RTM, Audit Trails, Gap Analysis, SDLC

Software: LIMS, AERS, Documentum, Track Wise, SharePoint

Operating systems: Windows, UNIX, Mac

Testing tools: HP ALM

Methodology: V - Model, Waterfall Model and Agile Model

PROFESSIONAL EXPERIENCE

Confidential

Sr. Validation Engineer

Responsibilities:

• Contributed to the applicable business, technical, regulatory, and procedural requirements for software implementations.
• Contributed to the company's Quality Standards and Procedures for Computerized Systems, as defined in Terumo CVS's governing Quality Management system.
• Responsible for executing the validation of non-product software applications including, but not limited to Enterprise Software, PDM system, CAPA Management system, Reports, Spreadsheets, MES system, Equipment and Automated systems(E&AS).
• Assisted to ensure audit readiness of the validated systems.
• Created validation and qualification deliverables, such as change impact assessment, user and functional requirement specifications, data migration plan, IQ, OQ, PQ protocol and scripts, qualification reports, etc. for new software, enhancements, maintenance, releases, and periodic reviews.
• Assisted in activities and tasks required to complete qualification and validation activities including reviews with Quality, obtaining signature approvals, executing qualification protocol or validation project plan, managing change control and remediation.
• Supported risk assessment and system lifecycle processes such as change control and document management.
• Contributed to systems validation in a regulatory environment, including systems, but not limited to process automation, enterprise systems, laboratory systems, spreadsheets, management dashboards, or quality systems.
• Proactively escalated issues and risks appropriately through proper channels.
• Performed other duties as assigned.

Confidential, NC

Sr. Validation Engineer

Responsibilities:

• Designed, implemented and validated 21 CFR Part 11 compliance strategies for LIMS.
• Played a major role in performing part 11 assessment, especially contributing to the components involved in the maintenance of Electronic Records (ER), Electronic Signatures (ES) and Audit Trails in accordance with 21 CFR part 11 regulations.
• Provided system support and configuration support required to maintain quality management solution.
• Wrote the technical specifications for new business processes, updated technical specs for improvement and generated validation documentation.
• Authored and reviewed the procedures pertaining to Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification protocols for the LIMS application.
• Analyzed User and Functional requirements to develop Test Plans, Test Cases and Test Scripts using HP ALM and executed them.
• Executed validation test cases based upon system requirement and FDA standards.
• Performed functionality testing for the entire application. Responsible for weekly status reports, updated showing the progress of Manual Testing effort and open issues to be resolved.
• Developed test cases and test scripts to perform regression testing. Tracked and closed the defects using HP ALM.
• Responsible for performing User Acceptance Testing (UAT) for the application.
• Maintained the Requirement Traceability Matrix (RTM).
• Involved in reviewing Corrective Action and Preventive Action (CAPA) and drafting Remediation plans for the project management approval after GAP analysis.
• Involved in writing the Computer System Validation Risk Assessment documents, Test Summary Documents and Validation Summary Report (VSR) to summarize overall validation activities.

Confidential, IA

Validation Analyst/Tester

Responsibilities:

• Responsible for assisting in the implementation of software systems in conformance with regulatory requirements as they pertain to 21CFR part 11.
• Reviewed and modified existing Standard Operating Systems (SOPs) for Document management system, System Administration, Change Control Procedures and Testing SOPs.
• Worked as business analyst and with HP TRIM as a part of record management system.
• Responsible for analysis, maintenance and administration of process management systems and quality management solutions environment.
• Communicated risk and compliance issues regarding PKS validation.
• Conducted meetings with the team members to point out the deficiencies in requirements and suggested the ways to cover it.
• Authored and reviewed the following types of documents: User/ Functional Requirements, Technical Design Specifications, Validation protocols (IQ, OQ, PQ) and validation final reports.
• Responsible for coordinating with team members in locating, tracking, organizing and verifying validation documentation for cGMP compliance and regulatory requirements.
• Reviewed the User Requirements and prepared the detailed Test Plans and Test Criteria.
• Developed, reviewed and executed Test Plans, Test Cases and Test conditions
• Involved in deficiency investigations, reviewing and preparing SOPs and quality system development.
• Designed and wrote training manual templates and was involved in project planning.
• Generated and submitted the weekly status reports.

Confidential, NJ

Validation Analyst

Responsibilities:

• Worked on AERS to capture all clinical trials.
• Implement Trackwise in conjunction with 21 CFR Part 11.
• Involved in generation of crystal reports and development of crystal reports.
• Involved in internal mock audit by quality organization.
• Responsible for generating and reviewing CSV deliverables in compliance with 21CFR Part 11 and GxP FDA Compliance Regulations.
• Documented the Vendor Assessment Report.
• Developed Design Specifications (DS) document. Used MS Visio for pictorial representation of the Design Specifications.
• Responsible for writing training manual and SOPs.
• Sharing knowledge for promoting best practices to be followed by project teams.
• Responsible for documenting IQ/OQ/PQ 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 the Validation Summary Report.

Confidential

Validation Analyst

Responsibilities:

• Gathered and analyzed business requirements, translated business requirements into system requirements.
• Used complete Software Development Lifecycle (SDLC) solutions, including requirements gathering, test planning and execution, design, development, and deployment
• Conducted user surveys to gather appropriate user requirements
• Co-ordinated meetings with stakeholders and project team to successfully map out timelines, milestones and communication process within the project
• Developed Validation Test Plan in conjunction with FDA regulations
• Involved in complete manual testing of the application
• Provided direct support and interacted with end users to solve publishing problems related to Documentum Management System
• Developed documentation for all aspects of the Computer System Validation Lifecycle, in accordance with FDA regulations, particularly 21 CFR Part 11, including: Validation Plan and Protocol, Installation Qualification (IQ), Operational Qualification (OQ)