PROFESSIONAL SUMMARY:

• Over 5 years of experience in Pharmaceutical and Biotechnology industries working as a Validation Specialist focusing on Computer System Validation, Equipment validation, Instrument Qualification, Cleaning Validation and Software Quality Assurance.
• Experience in Validation Methodologies, Medical Devices, Quality Assurance, Quality Control and Technical writing in Pharmaceutical Industry with a strong background in performing Computer System Validation and Software Development
• Having knowledge on SAS /BASE, SAS/MACROS, SAS/GRAPH, SAS/SQL, SAS/STAT, SAS/ACCESS and SAS/ODS.
• Working knowledge in CDISC and guidelines such as ICH, GCP, WHO Drug and MedDRA.
• Professional experience in Validation Practices with a good understanding of GxP (GMP, GLP, GCP, GAMP5) standards and 21 CFR Part 11.
• Experienced in development, execution and review of Validation Protocols IQ/OQ/PQ, VP, VSR, SOPs, Protocol Deviation, Risk Assessment, Decommission report, Periodic Review Report.
• Experience in developing and reviewing of all Validation end - to-end deliverables like SDLC documents, protocols and SOP’s to ensure they meet GxP and FDA regulations.
• Experience with Laboratory Information Management System (LIMS), Adverse Event Reporting System (AERS), Change Control Management System (CCMS), Document Management System, TrackWise.
• Handling of Laboratory instruments like HPLC, GC-MS, Auto samplers etc.
• Strong knowledge about pharmaceutical/medical device regulations like FDA 21 CFR Part 11, 21 CFR PART 210, 21 CFR PART 211
• Performed Negative and Positive testing.
• Expertise in reviewing and preparing Validation documents like Requirement Documents, Master Plans, Test scripts and Test cases and all Validation Deliverables.
• Developed and updated Validation Summary Reports (VSR), SOP’s
• Experience in Developing and reviewing User Requirement Specifications (URS), Functional Requirements Specification (FRS) and Requirement Traceability Matrix (RTM) Documents
• Experience in reviewing Corrective and Preventive Actions (CAPA) and highlighting and suggesting the remediation plans to mitigate the non-compliance.
• Well versed in phases of clinical trials and GCP as of 21 CFR 50 and 56.
• Good experience in Gap Analysis and documenting Remediation Plan.
• Efficient Communication skills, Proactive, Inquisitive, Multitasking and Team Player.

TECHNICAL SKILLS:

FDA Regulations: 21 CFR Part 11, Part 210, Part 211 and Part 820, cGMP, cGLP, cGCP, cGDP

Testing: Test protocol design, SDLC, Requirements Analysis, Test Plan Development and Implementation, User Acceptance Testing, Regression Testing, System Testing, Integration Testing using HPQC 10.0.

Operating System: Windows 98, 2000, XP, Vista, UNIX

Software: MS Word, PowerPoint, Excel, Visio, Project.

Database: MS Access, SQL Server 2000

SDLC/Methodologies: Waterfall, Agile,, V model

Programming Languages: SQL, SAS

PROFESSIONAL EXPERIENCE:

Confidential, Vernon Hills, IL

Process Validation Specialist

Responsibilities:

• Reviewed and approved the SOPs documented for the validation protocols.
• Reviewed Validation Master Plan (VMP) and Validation Protocols (IQs, OQs and PQs) in detail.
• Wrote test scripts & deliverables for validating Documented.
• Reviewed test cases and scripts and documented the results as per the FDA regulations.
• Involved in preparing compliance report about existing status of the cGMP, GCP and GLP.
• Involved in preparing documentation for all aspects of the computer system validation lifecycle in accordance with FDA regulations, particularly System Requirement Specification (SRS) and Performance Qualification (PQ) Specification.
• Followed Standard Operating Procedures (SOP).
• Developed a Validation Master Plan (VMP) to document the intent of validation effort in accordance with FDA regulation
• Gathered Traceability matrix and Performed Gap Analysis and prepared Remediation Plans to fix the gap identified.
• Assessed 21 CFR Part 11 requirements and analyzed organization’s current validation state.
• Developed SOPs and URS, IQs, OQs, PQs for validation of Computer systems specifically for the Electronic Records and Signatures.
• Maintain open communication with the LIMS team and Research customers to maximize resource usage.
• Proficient with Corrective Action Preventive Action (CAPA) workflow including Investigation, Investigation Task, Action, Request, Request Extension and Closure phases.
• Review tools for LIMS decision support to be used by the site. Analysis of LIMS enhancements, troubleshooting issues, second tier application support and routine master data configuration as required within the LabWare LIMS application.
• Assisted in writing and executing IOQ for Clean HVAC System final fill and wrote validation summary reports for O2, CO2 and Compressed gases.
• Performed Temperature mapping for ultra­low freezers, refrigerators and incubators using Kaye validator.
• Provided support in the preparation of IQs/OQs/PQs and Decommissioning protocols for manufacturing equipment such as Tanks, UV-VIS Spectrophotometers, Plate Readers, Autoclaves, Freezers, Refrigerators and Incubators in compliance with FDA regulations.
• Create and complete Change Control, Deviations, Investigations, SOPs and Impact Assessments.
• Conducted Vendor audits and prepared initial and final vendor audit reports.
• Gathered, documented, and obtained approval of Oracle EBS R12 business requirements
• Assisted the Project Manager in preparing Incident Reports as a part of testing process.
• Prepared and reviewed Validation Summary Repot (VSR) to summarize the overall validation effort.
• Actively participated in the weekly touch base meetings.

Confidential, King of Prussia, PA

Validation Specialist

Responsibilities:

• Followed Computer Systems Validation (CSV) Master Plan to author, review and approve CSV deliverables for systems as per GxP (GLP, GCP, GMP, GDP, cGMP) FDA Assessment.
• Authored, reviewed and approved CSV deliverables (Validation Project Plan, URS, TM, IQ, PQ, UAT, Vendor Postal Audit Report, Computer System Risk Assessment, Periodic Review Report, Decommission Report, and Validation Summary Report).
• Involved in validating the AERS (Adverse Event Reporting System) system and Quest-II (Query Evaluation and Surveillance Tool).
• Routed computerized systems documents (Validation Project Plan, URS, TM, IQ, PQ, UAT, Vendor Postal Audit Report, Computer System Risk Assessment, Periodic Review Report, Decommission Report, SOPs, and Validation Summary Report) using SAP and eDOCs for review and approval.
• Co-ordinate with the vendors in commissioning of the instruments (upgrade software, implement new system or maintenance of systems), system suitability tests, and resolving technical issues
• Generated SQL Queries in Documented Administrator to run the audit trail reports.
• Reviewed Oracle EBS suite module solutions based on functional specifications, and providing enhancements.
• Created the Production Qualification protocol to ensure the successful deployment of the application in production environment
• Assessed risks related to the systems and analyze them, if necessary with the Team.
• Directly work with QA for implementing new and upgrading previously validated systems.
• Validated systems used for GMP and Non-GMP purpose.
• Reviewed and followed SOPs to help the business process in line with FDA regulations.
• Organized and attended meeting to discuss the status of the projects.
• Involved in reviewing Corrective and Preventive Action (CAPA) and drafting Remediation Plans for the project management approval after the GAP analysis.
• Involved in Backend testing by executing SQL queries.
• Created Validation Summary Report (VSR) to summarize overall validation activities.

Confidential, Plainsboro, NJ

Validation Engineer

Responsibilities:

• Performed design verification pertaining to device QMS ISO 13485, 14971 for risk management.
• Maintained the laboratory in accordance to established cGMP, GLP, & 5S industry standards, conducted monthly audits of laboratory procedures and testing/product flow processes in order to identify potential areas needing focused improvements, and participated in internal and FDA audits as required.
• Utilized Documentum and created documentation in all phases of the SDLC.
• Performed Risk analysis.
• Performed the GAP analysis and Remediation Plans were developed for components that were not full and mostly compliant
• Developed the Functional Requirements Specification of LIMS by interacting with business users and development team and by using User Requirements Specification document.
• Developed the Validation Plan (VP) for SAP implementation by following the corporate guidelines.
• Collected User Requirements (URS) for Trackwise by interacting with the users and developed Design Specification (DS) for conformance with 21 CFR Part 11 based on the requirements.
• Developed Master Test Plan to strategize the testing approach to test SAP modules to meet the requirements defined in FRS.
• Close interaction with designers and software developers to understand application functionality and navigational flow.
• Created the strategy document that defines the LIMS test environment, phases of testing, entrance and exit criteria into different phases of testing and resources required conducting the effort.
• Prepared test data for Positive and Negative testing.
• Developed test plans and test cases for Functional and Regression Testing.