SUMMARY

• 6+ years of experience in Quality Control, Computer System Validation (CSV), equipment validation in an FDA regulated environment
• Expertise in GDP, working in GxP environment, ICH norms, IND, NDA and CMC guidelines
• Good knowledge of Validation Life Cycle, 21CFR (Part 11, 58, 210, 211, 820), 40 CFR (Part 160, 792) and GAMP 5 Guidelines
• Experience of working with stages of Software Development Life Cycle (SDLC)
• Quality experience in performing equipment qualification and validation, writing and executing Instrument Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) test scripts and validation protocols and SOPs
• Capable of developing and executing Test plans, Test scripts and Test case designs based on the user requirements
• Extensive experience in authoring and reviewing validation deliverables such as User Requirement Specifications (URS), Functional Requirement Specification (FRS) and Design Specifications, Validation Plan (VP), Validation Summary Report (VSR)
• Capable of generating and implementing Standard Operating Procedures (SOP's), Work Instructions and Administration Manuals
• Good knowledge of usage and understanding of Documentum, ATLAS, TrackWise, Argus, AERS
• Sound knowledge of usage and validation of Laboratory Information Management System (LIMS)
• Extensive experience in performing Cleaning validations and Instrument/ Equipment qualification and validation of analytical instruments including HPLC, GC, Karl - Fisher titrators, UV-VIS and FTIR spectrophotometers, DSC & TGA

PROFESSIONAL EXPERIENCE

Confidential, Longmont, CO

Validation Analyst

Responsibilities:

• Generated and reviewed Computer System Validation (CSV) deliverables in compliance with 21CFR Part 11, GxP and FDA Compliance Regulations.
• Drafted the Validation Strategy Document.
• Prepared the pictorial representation of Design Specification in the form of process flow diagrams using MS Visio.
• Developed standard documents for validation deliverables like User Requirement Specifications (URS), Functional Requirement Specification (FRS) and System Design Specification (SDS).
• Documented Vendor Assessment Report.
• Documented and executed Installation Protocol (IQ), Operational Protocol (OQ), Performance protocol (PQ) and reviewed them.
• Drafted and followed SOP’s for data backup procedures.
• Performed Data migration of legacy systems and ensured all the eCTD data and clinical reports are in compliance with the ICH (International Conference on Harmonisation) Safety Guidance.

Confidential

Responsibilities:

• Created strategies for following timelines for remediation process involved
• Met with team members to follow up on the Part 11 System Assessment reports for identify the findings
• Discussed the findings with Subject Matter Experts, in order to achieve resolution on the SOP updates
• Revised Standard Operating Procedures based on the remediation strategies, and changes in procedural control, conforming to 21 CFR Part 11
• Maintained SOP updates, and progress for various systems
• Routed documents for completion of their approval through Electronic Document Management System
• Worked with other team members to complete the project in the predefined timeline
• Created documents in Electronic Document Management System, and managing the document lifecycle in the system
• Worked on the Part 11 System Assessment, as a part of the Periodic Review of the system
• Facilitated a part of the Periodic Review, which includes system users assessment
• Created various System Manuals which would be used as a reference document for FDA Inspections
• Facilitated various documents in the Electronic Document Management System, to complete their approval

Confidential, Gaithersburg, Maryland

Validation Analyst

Responsibilities:

• Logged and tracked compliance issues and incidents using Trackwise
• Developed test scripts for testing the functionality of Trackwise
• Coordinated, led, and participated in weekly meetings to ensure timely execution of the project
• Reviewed change controls with accompanying documentation prior to approval and closure to ensure completeness, correctness, and adherence to standards
• Created, reviewed, updated, and routed documents using Documentum
• Developed test scripts for testing the functionality of the Documentum tool.
• Utilize Adobe and Documentum tools to develop and process documents
• Validation of documentum application
• Assuring that the VSCR (Trackwise) and RFC (SharePoint) are in appropriate status to ensure IT Compliance as per MedImmune standards to comply with FDA regulations
• Co-ordinated with Regulatory Operations to open a new Validated System Change Request in Trackwise to document the implementation of new upgrades
• Performed and reviewed Installation Qualification (IQ) Performed Operation and performance qualification (OQ/PQ) for various sites
• Developed and executed Test Plans and Test Scripts based on user requirements to verify complete functionality
• Conducted Data Driven Testing using Mercury QTP
• Reported test execution using Mercury Quality Center
• Reviewed the executed test scripts (UAT scripts) for approval
• Logged, tracked, managed, and closed change management requests pertaining to the laboratory information
• Extracted and drafted user and functional requirements for environmental monitoring application (MODA) from vendor supplied documentation (user’s guide)
• Created UAT test scripts for MODA
• Tracked and maintained deviations, exceptions during execution of UAT scripts
• Created the requirements traceability matrix (RTM) for the MODA application
• Executed and reviewed the test scripts, crystal reports for various reports and labels in MODA
• Involved in preparing the validation summary report documenting and elucidating all the discrepancies found during implementation and testing
• Assist team in assembling, testing, and fixing technical components. Record and update codes and design deliverables in keeping with standards.

Confidential, Memphis, TN

Process Validation Engineer

Responsibilities:

• Ensured compliance with all applicable regulations related to equipment validation.
• Generated new user requirements by incorporating critical and desirable equipment/ process specifications.
• Improved the existing templates in terms of content, reasoning and technical writing.
• Written validation protocols, prepare validation Data collection forms, a checklist of common requirements and written report with data analysis and conclusions.
• Performed and reviewed process/ equipment validations, IQ, OQ, and PQ of machining equipment like - CNC Mills, Swiss turn Lathes, EDM’s and special processes - Laser Mark, Laser sintered, Grit blast cabinets, Heat Treat Ovens and Dispatch Ovens.
• Conducts risk assessments and PFMEAs required for process validation.
• Performed Gap Analysis for legacy equipment on a remediation plan.
• Utilizes advanced statistical tools to determine sampling plans and to analyze data associated with validation activities.
• Responsible for creating validation documentation in Matrix PLM (Product Lifecycle Management) software and promoting it for further reviewing and all approvals.
• Interfaces with Quality and Manufacturing Engineers to review processes, determine validation requirements, coordinate the validation activities and performs testing related to the validation.
• Works with management, Engineers, and Manufacturing Associates in the resolution of quality problems associated with the validation project.

Confidential, Spring Valley, NY

Validation Engineer

Responsibilities:

• Authored the required documents like validation strategy, work instructions to perform testing, protocols for development studies, operational and performance qualification, completion and validation summary reports.
• Generated and executed IQ/OQ/Cleaning Validation (CIP, SIP) Protocol, collected field samples, performed visual inspection of cleaned components / equipment and did troubleshooting of failures / residual problems.
• Revising and monitoring current cleaning and sanitization procedures related to CIP systems, cabinet washers, COP, manual cleaning(rack layouts/ arrangements) and providing training for these procedures.
• Providing assistance to cleaning process development validation.
• Provided technical support to engineers on the matters of validation.
• Assisted with utilities, facility and water validation processes and activities.
• Review and approve cleaning procedures for cleaning production and packaging equipment, generated risk assessments to discuss the approach to cleaning related activities.
• Supported the rational for the selection of product markers to detect trace levels of drug product and drug substances.