SUMMARY

• Over 8 years of experience as a Computer Software Validation Analyst and Quality Assurance professional in Pharmaceutical and Biotechnology companies validating ERP, LIMS, AERS, Empower 3 and other IT systems in support of compliance with GxP procedures 21 CFR Part 11 .
• Experience in providing computer validation direction and oversight to project teams by giving guidance on computer validation requirements and by reviewing validation deliverables to ensure compliancewith FDA regulations.
• Perform Quality review of documents, pre and post approval review of Test Scripts (IQ.OQ.PQ)
• Experienced in User Acceptance and Software Testing, Business and Requirements Analysis, Release Management and Technical Documentation spanning the full cycle of product development. Validation: In - Process, Equipment/Instrument and software development life-cycle, Infrastructure.
• Expertise in Reviewing, Authorizing and Approving validation protocols for qualification of systems; design specifications; Periodic Review, trace matrices; test protocols (IQ/OQ/PQ); summary reports; vendor audit reports; gap analyzes and risk assessment reports, CAPA; SOPs and policies.
• Extensive knowledge about Software Validation life cycle; FDA requirements, ICH standards, Document management systems (Documentum), Records Management, cGMP/GLP/GCP, GAMP and validation in FDA regulated environment.
• Familiar in Manual Testing, HPQC, HP ALM, Docspace, SAP ERP, Defect Tracking, Defect Management and Track wise tools.
• Experience in working in a fast paced environment to meet deadlines in a timely manner, ability to manage multiple projects at the same time
• Solid leadership skills in defining and implementing quality processes within the product development lifecycle. Good communication skills clubbed with excellent interpersonal skills.

TECHNICAL SKILLS

Software Packages: e-lab and Fusion LIMS, Empower, Track wise

Testing Tools: HP QTP, HP QC, ALM & Docspace EMS

PROFESSIONAL EXPERIENCE

Confidential, Skillman, NJ

CSV QA Consultant

Responsibilities:

• Followed SOPs and Project Compliance Plan in carrying out different validation / testing activities.
• Reviewed CSV deliverables for the above projects in accordance with FDA regulations & 21CFR Part 11:
• Compliance analysis, Compliance plan, Periodic review, FRS, URS, System Test, UAT, Compliance Report, Trace Matrix and Summary Report.
• Performed pre and post execution review of validation Test Scripts by Manual Testing for the above mentioned projects following industry best practices and compliance role including quality approval.
• Identified Test defects and helped in creating Test Defect Reports (TDR). Also reviewed TDRs for completeness and accuracy.
• Performed Pre and Post Execution Review and approval of the Test Scripts, Requirements and Defects in HPQC 10 and HPALM 11 for LIMS, Empower, ESS and Web UAR Projects.
• Reviewed and approved documents in the docspace electronic management system for ESS project.
• As a part of the team was responsible to track the project activities through Excel.
• Provided CSV QA Guidance During Testing.
• Reviewed Change controls: Incident management, Change request and change orders in SAP Solution Manager and Charam
• Reviewed FDs for change orders
• Provided QA guidance to RTP(Requisition to Payment) and CTC(Customer to Cash) teams for Consent Decree project in creating FD documents in Solution Manager
• Participated in Internal audits: Extracted the documents from release 1 to release 6 in charm(SAP)

Confidential - NJ

Validation Specialist

Responsibilities:

• Provide computer validation direction and oversight to project teams by giving guidance on computer validation requirements and by reviewing validation deliverables to ensure compliancewith regulations.
• Involved in Authoring and reviewing CSV deliverables in compliance with 21CFR Part11 and GxP FDA Compliance Regulations
• Reviewed and executed validation protocols for different custom database applications according to 21 CFR part 11 compliance
• Perform pre andpost execution and approval of test scripts on behalf of Validation Compliance
• Involved in the technical writing of Functional Requirement Specifications and Test Plans(OQ and PQ), Summaries.
• Involved in Computer Systems Validation according to FDA Guidelines, GMP and (21CFR Part 11)
• Involved in preparation of Validation Plan Document
• 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
• Authored IQ/OQ/PQ protocols, and prepared a Validation Summary Report document

Confidential - Long Island, NY

Validation Analyst/Reviewer

Responsibilities:

• Involved in reviewing the Functional specifications
• Involved in reviewing the User Requirements
• Involved in performing the risk assessment.
• Perform pre andpost execution approval of test scripts on behalf of Quality & Compliance, reviewed the test scripts for Consistency, Clarity and Completeness.
• Involved in developing test strategy and data setup for OQ and PQ protocols.
• Executed validation guidelines for testing the GMP sensitive environment.
• Involved in preparing the Requirement Traceability Matrix.
• Developed various test Templates for conducting the Protocol execution.
• Reviewed the pre and post approval test protocols for SAP - MM, PP, QM modules
• Developed validation guidelines for testing.
• Perform Quality review of the OQ and PQ Test Summary Reports.
• Author the Validation Summary Reports.
• Guided the team members in Document Control and Change Control Management practices.
• Conducted the test execution and deviation management resolution.
• Trained the testers in Good Documentation Practices and company SOP’s.
• Reviewed Deviation Reports for the issues arising out of the OQ, PQ testing and project related issues and coordinated with the QA department of the final acceptance.
• Coordinated and guided the offshore test resources.

Confidential

Validation Analyst Trainee

Responsibilities:

• Involved in Computer system validation according to FDA guidelines, in support of Track wise Quality Management System & elab Lims.
• Involved in preparing Validation Master Plan, Risk Assessment, Test Protocols
• Responsible for documenting test plans that contains Test scripts, Test cases, test data and expected results for user acceptance testing.
• Developed plan and Performed computer system validation for all the phases of the SDLC for existing system ensuring 21 CFR part 11compliance
• Developed Compliance Plan for phasing out the old CAPA system, and replacement with Trackwise CAPA and ECC (Electronic Change Control)
• Interacted with internal departments, which are not limited to quality, production and other lead users in order to develop/review User Requirement Specification and functional requirement specification and consequently Requirement Traceability Matrix.
• Maintained documentation, involving change controls, deviations, incident reports.