SUMMARY

• Over 7+ years of experience as Process Validation/Compliance Engineer Consultant, Validation Engineer, Equipment Validation Analyst/ QA/ Technical Writer in Pharmaceutical, Healthcare, and Medical Device Industry.
• Working experience in computer system validation in compliance with FDA regulations, including Laboratory Information Management System (LIMS) and Scientific Data Management System (SDMS).
• Extensive experience in authoring and executing all system qualification documentation including Validation/Test plan, user and Functional Requirements Specification, Test cases/scripts, Requirements Traceability Matrix (RTM) for IQ/OQ/PQ protocols and summary reports with exposure to full Validation Life Cycle.
• Extensive Experience in reviewing Standard Operating Procedures(SOP), Validation Master Plan(VMP) and Validation Summary Reports (VSP)
• Industrial experience and Good understanding of FDA’s 21 CFR Parts 11, 50, 56, 58, 210, 211, 312, 314 and 820; ICH - GCP Guidelines and ISO 13485
• Adept knowledge about analytical laboratory procedures, experience in operating troubleshooting and supporting analytical equipments like HPLC, GC, UV-VIS Spectrometers, Spectrophotometer, Autoclaves, pH meters and incubators.
• Good understanding of automated process control systems, clean room and classified area requirements for Aseptic Environment.
• Good Knowledge about Waterfall and Agile Scrum Models of SDLC
• Adept knowledge and experience with Adverse Event Reporting System (AERS), Laboratory Information System (LIMS) and Electronic Document Management System (EDMS)
• Expertise in Corrective Action Preventive Action (CAPA) analysis of the project
• Involved extensively in Functional testing, System testing, Integration testing, Performance Testing, load testing and Regression testing, both Manually as well as using Automated testing tools including Quick test professional (QTP), Quality Center, Load Runner and all IBM testing tools.
• Expertise in database testing with SQL to verify data integrity.
• Possesses excellent written and verbal communication skills with strong abilities in requirement capture, analysis, design and development in large application development projects.
• Ability to communicate effectively, enthusiastic, self-motivated, and highly organized.

TECHNICAL SKILLS

Equipment/Cleaning Validation: Autoclaves, HPLC, UV Spectrophotometers, GC, pH Meters, TFF skid, CIP Skid, Incubators, Freezers, Spray Dryers, Isolators and Bioreactors

Computer System Validation: 21 CFR part 11, 820, GxP, SDLC, VMP, IQ, OQ, PQ, SOP,LIMS, AERS, ISO13485

Programming Languages: BASIC, C, SQL, UML

Testing tools: QTP and Quality Center

Application Software: Windchill, service now

Databases: SQL, Oracle 10g and MS Access

Operating Systems: Windows 98/2000/XP/vista/7, IOS, UNIX and LINUX

PROFESSIONAL EXPERIENCE

Confidential, Philly, PA

Validation Analyst

RESPONSIBILITIES:

• Created and Executed Site Acceptance Test (SAT) Protocol and Drafted Final summary report.
• Reviewed and approved Validation Protocols (IQ, OQ and PQ) for HVAC, UFDF, Chromatography, Centrifuges, Refrigerators, Freezers, and Incubators.
• System Periodic Reviews (Validation Maintenance) were performed following “Shire Validation Maintenance Procedure” and “Validation Maintenance Transition Plan”.
• Identified Exceptions in SAT and addressed deviations by Corrective and preventive actions Plan (CAPA).
• Involved in Validation Process and documentation of Validation Project Plan.
• Validated lab equipment like Solo VP with Cary-60 spectrophotometer, Spectrophotometers, Mass Spectroscopy and Plate Readers.
• Conducted GAP analysis to identify compliance of 21 CFR PART 11 and formulated Remediation Planning.
• Reviewing and re-authoring all cleaning documents projecting consistency and detail to meet industry standards and comply with regulations.
• Identified Exceptions in SAT and addressed deviations by Corrective and preventive actions Plan (CAPA).
• Reviewed and approved Validation Protocols (IQ, OQ and PQ) for Refrigerators, Freezers, Incubators.
• Worked under FDA regulations and strict GAMP environment.
• Managed system upgrades, enhancements, and maintenance in a cGMP environment
• Drafted Requirement traceability matrix (RTM) after qualification to identify Gaps.
• Generated and reviewed the validation deliverables with in specified time frames.
• Developed Validation summary reports.

Confidential, Mahwah, NJ

Equipment/CSV Validation Engineer

RESPONSIBILITIES:

• Involved in compliance review and coordination of vendor protocols for protocol generation, execution and summary of various pieces of new equipment such as Tanks, CIP skid, TFF skids, Spray dryers and Isolators.
• Involved in designing procedures and test methods which comply with business, FDA and industry best practice guidelines: FDA’s 21 CFR820 and 11; ISO 14971 and 13485, GMP and GAMP 5
• Collected and analyzed user requirements and detailed design specifications, functional requirement specifications to develop VMP, SAT, IOQ’s and risk analysis.
• Involved in the development of Requirement Traceability Matrices (RTMs) for spray dryer.
• Maintaining and updating Requirement Traceability Matrices (RTM) to track requirements that co-related with the conducted test cases for Isolators, CIP and TFF skids.
• Assisted in Drafting the documents such as Validation Master Plan (VMP), Site Acceptance Testing (SAT), Installation and Operational Qualification (IOQ) and final reports for tanks, spray dryer and isolator.
• Reviewed the system related SOPs to ensure compliance of company’s processes, policies, and procedures.
• Authored Happy Path scripts For UAT and provided the users with all the support needed for them in UAT to understand the current process and how it is different from the old workflow.
• Performed Dry run of all the Test scripts and recorded all the Deviation through the Issue Log in all the environment.
• Assisted in drafting the Test script for New Requirements by following the GDP guideline.
• Performed Informal User Acceptance Testing in the INT environment and also tracked all the issue through a Deviation log.
• Responsible for routing the documents and also ensuring that all the script is PRE approved for QA validation and Execution.
• Reviewed al, the QA executed scripts and ensures all the evidence has been collected and all the Deviation were captured and documented.
• Performed the Formal validation in QA and reported Deviation through the Standard Deviation log.
• Expertise in identifying the bugs and analyzing the bugs are system related or script error.
• Assisted the IT Team in all the documentation like AIQ, Promotion documents and also uploading all the QA scripts and evidence to the share point.
• Assisted in validation test summary report, validation summary report and also assisted in bulk configuration of the user groups as a Pre - Go- live Activity.

Confidential, NY

Validation Consultant

RESPONSIBILITIES:

• Performed and executed Validation, Qualification and Re-Qualification protocols for the Manufacturing Equipment /Process and aseptic areas.
• Authored validation documents independently such as OQ and final summary report for the retrospective qualification of HPLC columns.
• Authored validation documents such as IOQ for the qualification of new replacing HPLC columns
• Executed Operational Qualifications (OQs) to make sure that the columns are capable of consistently operating between established limits and tolerances.
• Worked with Document Management System for managing technical documentation of project.
• Assisted the project manager in documenting SOPs, review of Batch Records in developing procedures for proper resin packing method in production phase
• Ensured complete 21CFR part 11 compliance assessments for manufacturing systems
• Involved in documenting the Validation Master Plan in accordance with FDA regulations, particularly 21 CFR 210, 211, GLP and GMP

Confidential, NJ

Equipment Validation Engineer

RESPONSIBILITIES:

• Validated equipments such as chromatograph, bioreactors, autoclaves, and Incubator in compliance with FDA regulations.
• Involved in documentation of validation protocols e.g. Validation Master Plans, User Requirements Specifications, Functional Requirement Specifications (FRS), IQ, OQ and PQ protocols, Validation Reports, and Requirement Traceability Matrix (RTM) per Merck approved Policies and Procedures.
• Prepared and executed Validation and Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for process equipments such as autoclaves, mixers, Bioreactors, Tanks, and Lyophilizers in compliance with cGMP and FDA regulations.
• Performed temperature mapping, thermocouple calibration, sterilization, heat distribution, penetration, three biological indicator studies for various process equipments.
• Drafted standard operating procedures (SOPs), and supported QA audits of existing operating procedures to ensure the compliance with company current regulatory requirements.
• Well versed with FDA regulations and working knowledge of cGMPs and documentation requirements including 21 CFR 11, 210, and 211.
• Wrote validation summary reports for chromatography system, bioreactors, autoclaves, and purification systems.
• Ensure that all the documentation is compliance with FDA and CGMP regulations and provides technical support to the validation group as needed.

Confidential, Hilltown, PA

Validation Engineer/Specialist

RESPONSIBILITIES:

• Involved in protocol generation, execution and summary of various pieces of new and relocated equipment (autoclaves, depyrogenation oven, controlled temperature units, etc.), and the compliance review and coordination of vendor protocols for bench-top equipment (HPLCs, DNA Synthesizers, etc.).
• Developed SOPs and IQs, OQ’s, PQ’s for validating HPLC system specifically for the Electronic Records and Signatures
• Reviewed Autoclave validation by developing validation cycles and load configurations.
• Translated business specifications into User Documentation
• Involved in Validation (IQ/OQ) of instruments and qualification of automated control system.
• Worked with QA/Compliance to track and coordinate any validation change control and/or corrective actions.
• Assessment for compliance with 21 CFR Part 11 (Electronic Records and Signatures), 21 CFR Part 211 (cGMP for Pharmaceuticals).

Confidential

QA analyst/Quality Control

RESPONSIBILITIES:

• Assisted in the development of validation master plan (VMP) and standard operating procedures(SOP)
• Prepared, reviewed and approved validation protocols for Manufacturing/ Packaging(Fluid Bed Dryers, Filler machines, Tablet Press Machines, Autoclaves and V- Blenders) and laboratory(FTIR, HPLC and TOC) systems
• Identified and assessed the impact of change control activities for validated equipment, software and systems
• Conducted periodic validation of equipment as well as software and documented the validation results as dictated
• Assisted the QA team in composing internal audit reports for regulatory submissions
• Performed quality control tests including disintegration tests, dissolution tests, and UV analysis to assess the quality of the pellets