- Seven years of experience in Validation with strong background in Computer System Validation, Software Development Life Cycle, Technical Writing along with performing Manual and Automated Testing in the Pharmaceutical/medical industries including specialization in 21 CFR part 210,211,820 compliance and GAMP, GxP’s (GMP, GLP and GCP).
- Excellent experience in the validation of highly regulated enterprise level business systemsSiebel CRM, Laboratory Information Management System (LIMS), Clinical Trial Management System (CTMS),Adverse Event Reporting System (AERS), TrackWise, Inventory Management System and Remedy..
- Good working experience with LabWare LIMS software involving tracking raw materials and samples, modelling work flows, managing data collection and reporting and communicating this information to corporate systems, end users.
- Experience in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA, MHRA rules and regulations.
- Experience in utilities and facilities qualification, equipment qualification, and computer validation.
- Experience with Factory Acceptance Test (FAT).
- Good understanding of 21 CFR Part 11, 210, 211, 820, GAMP 5 and associated FDA, GCP/ICH guidelines.
- Full validation life cycle experience including developing and maintaining SDLC for validated systems, Validation Plans, IQ/OQ/PQ/RTM, and validation reports.
- Developed and reviewed Test Plans, Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ), Test Summary Report and Requirement Traceability Matrix (RTM).
- Expertise in developing Test Strategies, Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and testing standards.
- Experience in using quality center to manage testing artifacts.
- Performed GAP analysis in identifying compliance gaps.
- Developed and implemented corrective action and preventive action plans (CAPA).
- Experience in preparing Risk assessment, Regulatory Assessment, Technical Assessment, Remediation Plan and Deviation Reports for FDA regulated environment.
Tools: Quality Center, MS Office Suite Word, Excel, PowerPoint, Outlook, MS Visio, MS Project.
Operating System: Windows/Vista
Waterfall, V: Model, Spiral, and Agile.
21CFR Part 210: 211 (cGMP s),GAMP 5, 803 (Medical Device Reporting), 820 (Quality System Regulation).
Validation Deliverables: Validation Plan, Test Plan, Compliance Risk Profile, RTM, URS, FRS, OQ, PQ Protocols, Sop s/Work instructions, System problem reports and System Certification Summary/Compliance Report.
Laboratory Equipments: Gas chromatography/Mass chromatography (GC/MS), Liquid chromatography(LS), Scanning Electron Microscope.
Confidential, Memphis, TN
- Medical device analysis and remediation. Device History File: Product and Market Specifications. Test method validation, testing as per appropriate SOP.
- Statistics Process Control to comply with International, Standard such as ISO 13485. Performed Process development, and packaging validation review per ISO 11607.
- Design controls: performed design of experiments, new product introduction process; FMEA’s, GR&R, specification development, generated ECO’s, and performed validation/ verification. Improve the Corporate Quality System in the area of Statistical Analysis application for DV&V and PV&V, Test Method Validation (MSA), Risk Management per ISO14971 including FMEA. Integration of process control into product development during product design.
- Quality Management Systems. Designed test fixtures using Solid works, developed test methods, and executed gage R&R methods.
- Analyzed the Business requirements and prepared the Validation Master Plan.
- Maintained 21 CFR Part 11 compliance for computer systems by conducting Risk Assessments, identifying compliance gaps, and developing Remediation Plans.
- Developed the Electronic Records and Electronic Signatures Assessment document by performing Part11 assessment to the components involved in maintenance of Electronic Records, Electronic Signatures and Audit Trails in accordance with 21CFRPart11 regulations.
- Developed the User Requirements Specifications (URS), Functional Specifications (FRS) and the Design Specifications document (DS).
- Reviewed and updated end to end validation documentation for TrackWise to ensure compliance with company policies and procedures.
- Ensured documentation meets quality standards, applicable regulatory compliance and company guidelines.
- Involved in the validation of EDMS, GxP Assessment database, Change Management System Developed, reviewed and approved the Installation Qualification, Operational Qualification and Performance Qualification test scripts to check if all the functional requirements are met.
- Responsible for building test cases, test procedures and test reports.
- Performed assessment audits of systems creating gap analysis - comparing ISO 9001 QMS to ISO13485. Up-dated systems incorporating ISO13485 elements established DMR and DHF, upgraded change control (ECR/ECO) process. Wrote/rewrote procedures, inspection instructions.
- Provided validation and quality engineering support: Developed training on meaning and content of Installation, Operational, and Performance Qualification (IQ/OQ/PQ) procedures. Performed as R&D QE design/development engineering activities.
- Established and Maintained Device Master Records (DMR)/ Design History files (DHF) - Design Reviews, Validation/Verification, IQ/OQ/PQ documents and Change Control process. After verification testing reviewed the test results for accuracy and completeness
- Implemented process controls for product and process improvements. Supported Inspection, 1st Article, In-Process- BOM's-WIP, Tests and MRB. Created data collection methods and statistical process control (SPC), Cpk, parato, yield, and trending reporting.
- Wrote and revised SQP's, labeling review, and document review prior shipping. Protocol Writing and Execution: Wrote/executed Commissioning, IQ/OQ/PQ, & Process Validation protocols
Confidential, Framingham, MA
- Documented various validation deliverable of system life cycle as required by FDA regulations under 21CFR Part 11.
- Reviewing the User Requirement Specification (URS) and the Functional Requirement Specification (FRS) document and analyzing the causes leading to discrepancies and failure of the pre-executed OQ scripts.
- Created design verification protocols/reports and test method to ensure each claim has supporting evidence in the DHF.
- Involved in creating test bed to check the Installation and Operational Qualification (IQ/OQ) for the application.
- Performed the ERES assessment of the overall functionalities of Argus Safety and evaluated the functionalities with a risk assessment based on the impact to the three core criteria: patient safety, product quality and data integrity and defined the testing strategy.
- Proficient in Minitab, Gauge R&R, AutoCAD, Master Validation Plans (MVP) and many other useful software programs. Broad knowledge of GMP, FDA, ISO, SOP, OSHA regulation and Quality Standard regulations.
- Hands on experience in Design controls and DHFs. Lead investigations with the team to root cause and the development and implementation of corrective action plans.
- Experience in Gathering and Analyzing Business requirements from the stakeholders and clients, followed by GAP Analysis.
- Strong understanding of GAMP 5 guidelines; GxP (cGMP, GDP, GCP, GLP) standards; 21 CFR Part 11, 58, 210, 211 and 820; Computer System Validation and Validation Life Cycle.
- Strong experience performing equipment qualification and validation, writing and executing Instrument Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) test scripts and validation protocols
- Practical knowledge of Business Process Modeling, SOA, Data Analysis, Data Mapping, writing BRD (Business Requirements Document), FRD (Functional Requirements Document), Use Cases and UAT (User Acceptance Testing).
- Experience in Data Migration, Periodic Review, GAP Analysis, and Risk analysis, FMEA and Remediation Process.
- Implemented GxP (GMP, GCP, and GLP) and GAMP guidelines in the systems.
- Performed TMV’s for Visual Inspection dimensional measurements.
- Developed Operation Qualification (OQ) test scripts for TrackWise Change Management modules and CAPA system.
- Drafting the Requirement Traceability Matrix document to track the URS and FRS are fulfilled by executing the OQ and PQ scripts.
- Prepared detailed SOPs for IQ and PQ for validating Autoclaves and HPLC detailing more on Filter sterilization, saturated steam checks including vendor specifications.
- Authored Requirement Traceability Matrix (RTM).
Confidential, Franklin Lakes, NJ
- Followed Computer Systems Validation (CSV) Master Plan to author, review and approve CSV deliverables for systems as per GxP (GLP, GCP, and GMP) FDA Assessment.
- Profound knowledge in pharmaceutical/medical device regulations like FDA 21 CFR Part 11, FDA 21 CFR part 820 and ISO 13485.
- Involved in the creation of Validation Plan, Verification Protocols and Verification Summary report documents.
- Acted as HP ALM admin and was responsible for uploading requirements into HP ALM.
- Equipment validation and Technical documentation as per FDA/ISO 13485 and GAMP regulations.
- Maintained CAPA procedure, initiated investigation of non-conformances through root cause analysis (RCA), evaluation of the effectiveness of CAPA process, and initiation of action as required improving effectiveness.
- Analyzed test scripts to be compliant with 21CFR Part 11 regulations, maintaining validation Electronic records and following relevant SOPs.
- Provided systems engineering input, including requirements development and risk Validation assessment, for Design history file (DHF) remediation and new product development (NPD)
- Perform risk management assessment on all new and existing products.
- Perform Functional Verification/Validation Testing as per the features of the product.
- Provided validation guidance to SAP functional teams to ensure compliance to the regulations like 21 CFR Part 11, GDP and GMP.
- Developed Validation Master Plan (VMP) in accordance with FDA compliance standards
- Developed IQ/OQ/PQ and MSA protocols by identifying inspection and test activities, special measuring and test equipment, appropriate statistical techniques, data collection methods, and sampling plans for establishing, controlling and verifying process stability/capability.
- Involved in preparing compliance report about existing status of the cGMP, GCP and GLP.
- Involved in reviewing Validation deliverables Validation Master Plan (VMP), Validation Summary Documents (VSD), Validation Summary Reports (VSR), Installation Qualification/ Operational Qualification/ Performance Qualification, and Requirements Traceability Matrix.
- Develop and execute verification tests for client systems (i.e. medical software)
- Reviewed validation (IQ/OQ/PQ/PPQ/TMV) and provided technical input to ensure validation reports were qualified to company and regulatory requirement.
- Involved in auditing the application for 21 CFR Part 11FDA 21 CFR part 820, IEC 60601-1, ISO 13485, and ISO 14971. Compliance related to Electronic Signatures and Electronic Records for Trackwise System.
- Experience in Data Migration, Periodic Review, Change Controls, and Change Reporting, GAP Analysis, and Risk analysis, CAPA, FMEA and Remediation Process.
- Performed Statistical analysis for the FMEA risk assessment and performed Fault Tree analysis.
Confidential, Kalamazoo, MI
- Performed Test validations procedures, for dialysis machinery. Generate and execute validation test protocols and testing's. Conducted CAPA, continuous improvement, audit, quality systems and assurance, etc.
- Interacted with supplier for failure analysis report for components such as Supplier Corrective Action report as part of NCR and CAPA system.
- Provided effective support in all the stages of engineering design change process and document control. UDI project to change renal product labels to meet GS1 standards using change control process
- Developed supplier production parts by utilizing GR&R, Process Quality Control using SPC, Test Method Validation (TMV), Process Validation (IQ/OQ/PQ), Process Capability study, and First Article Inspection.
- Working on Critical activities like labeling subsystem requirements update, Event Based Risk Review, Label content approval, Labelling verification Report, Instructions for Use study, Trace matrix update, RACT update & DHF index update etc.
- Detailed & complex analyses & tests requirements, FRS, performed test cases for research, and development. Executed Validation data analysis, reports, and recommendations for changes and/or improvements. Created test methods and fixtures for destructive strength tests.
- Developed and executed protocols for package design, packaging processes validation and package shelf life testing. Write protocols, perform studies, and evaluate the protocol test results, in accordance with 21CFR part 1
- Monitored and received Product Lifecycle Management notifications for Engineering Change Orders pertaining to LIMS , ensured all corporate specifications were accurately transcribed into the LIMS database. Profound knowledge of Quality System Regulations for medical devices and pharmaceuticals such as, 21CFR Part 11, 21, 210, 211, 820, ISO 13485, cGxP (GMP, GCP, GDP and GLP).
- Expertise in writing and executing Validation Protocols and authoring Reports (IQs, OQs and PQs). Supported CAPA Remediation process by reviewing retrospective supplier CAPAs for completeness to address CAPA plans, root causes, implemented corrective actions and effectiveness checks.
- Experience using continuous improvement tools, such as FMEA, Root Cause Analysis, SPC analysis, PPAP, APQP and process mapping.
- Experience in Reviewing/Writing/Updating current operating procedures and developing new Standard Operating Procedures (SOPs) and train users on SOPs for many analytical instruments and manufacturing methodologies.
- Professional with proven experience in quality systems regulations (QSR), supplier quality, remediation and CAPA projects, new product development, internal/external auditing, test and manufacturing, Equipment & quality assurance for medical device manufacturing.
- Expertise in product failure analysis, DHF/FMEA assessment, Risk Management (ISO 14971), process improvement.
- Strong experience in Software Development Life Cycle (SDLC) and Agile Scrum/waterfall methodologies