- 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.
- Professional experience in GXP (GMP, GLP, GCP), 21 CFR Part 11, GAMP5 for Pharmaceutical/Biotech manufacturing.
- 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.
- Excellent knowledge and experience in configuring and validating StarLIMS, SQL *LIMS
- Developed interfaces with laboratory instruments using StarLIMS Scripting Language
- Very proficient in writing Validation Summary Report (VSR) and Test Summary Report (TSR).
- Strong hands on experience in using Win Runner, Load Runner and Test director.
- Ability to work both independently and in a team-oriented working environment.
Tools: Quality Center, MS Office Suite Word, Excel, PowerPoint, Outlook, MS Visio, MS Project.
Operating System: Windows/Vista
Methodologies: Waterfall, V-Model, Spiral, and Agile.
FDA Regulations: 21CFR Part (cGMP’s),GAMP 5, 803 (Medical e 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, Chicago, IL
- Maintained Requirements Traceability Matrix (RTM) to track requirements
- Involved in reviewing Corrective Action and Preventive Action (CAPA) and drafting Remediation plans for the project management approval after GAP analysis.
- Loaded IQ, OP, PQ, TMV documents into PDM (Product Data Management) system, (a controlled document/data management system) for review and approval signatures.
- Created validation products including Validation Scripts, Toolkits, Documentation, and Services (21 CFR Part 11, GAMP 5, ICH Q8/Q9).
- Using a risk-based approach, provided guidance on System Development Life Cycle (SDLC) and Computer System Validation (CSV) requirements for the implementation of all computer systems in compliance with Ricon Pharma's Quality Management System and GxP regulations.
- Involved in all aspects of the computer systems validation lifecycle, to comply with FDA regulations.
- Involved in Calibration and Validation of Laboratory Instruments TOC-Analyzers, UV Spectrophotometers, Water baths, Centrifuges, Densitometers, Plate Readers and Imagers.
- Was involved in gathering User Requirements, conducting Gap Analysis and preparing the Remediation plan.
- Hands on experience in cleaning validation of various commercial solid dosage form equipment.
- Validation Subject Matter Expert for CSV activates performed by functional areas(e.g. analytical laboratory, manufacturing).
- Was involved in monitoring the processes that governed various tests like Bowie Dick test, Steam Penetration Test involving different activities like Flow rate Precision, S/N ratio and temperature control parameters.
- Prepared detailed SOPs for IQ and PQ for validating Autoclaves and HPLC detailing more on Filter sterilization, saturated steam checks including vendor specifications.
- Authored and executed CSV IQ/OQ and PQ activities for Clean-In Place (CIP) systems throughout the facility and USP PLC/HMI automated RO purified water distribution system.
- Reviewed and identified gaps in TMV protocols and reports for remediation/revalidation.
- Documented all materials during the testing phase of the project.
- Created for the use of SDLC/UAT / Business Procedural documentation for the Reporting.
- Trained operators for best practices to improve energy conservation efforts in Autoclaves, Refrigerators, Freezers, and Ovens which resulted in reduction of utility bills, downtime and maintenance costs.
- Monitored the testing conducted by QA department and documented the Validation Summary Reports.
Confidential, Menomonie, WI
- Support cGMP program including: Risk Analysis, Change Control, and Standard Operating Procedure using QUMAS. Support Site Expansion and Renovation activities including Commissioning and Qualification for Facility, Utility and Equipment related systems.
- Performed Gap Analysis, documented and defined the gaps and wrote Remediation Plan to bring the system in compliance with Regulation and participated in preparing the implementation plan.
- Extensive experience on Test Method Validation (TMV) for attribute and variable and analytical test methods.
- Working with the validation team leader, created the customer specific Equipment Installation and Operational Qualification Protocol (IOQ) standardized template, along with the templates for the Process Operational Qualification Protocol (OQ) and the Performance Qualification Protocol (PQ), intended for Phase I, II, Clinical Trials and Phase III of the Pilot Program development process.
- Ensured adherence by staff to quality, regulatory and GxP standards.
- Involved in all phases of SDLC according to Company procedures, FDA Guidelines, GMP.
- Performed V & V for all approved product contacted areas and product/process materials used.
- Authored and Executed IOQ, OQ and PQ protocols for a variety of automated assembly systems and on - line inspection and test systems, inclusive of software and/or firmware/hardware and PLCs systems.
- Created documents such as PFMEA, MVP, TMV, IQ, OQ, PQ etc.
- Received Company correspondence expressing appreciation for accomplishment contributions made.
Confidential, Ann Arbor, MI
- Support production engineering change orders supporting FDA remediation activities for various platforms including: Heart Lung Machine, Machine Shop, and Incoming Quality Inspection.
- Developed project plans and strategy supporting design transfer activities from the development phase to release into manufacturing.
- Support Design Transfer activities including: Technical Reviews, Gap Assessments, Effectivity Forms, Pilot Reports, Control Plans, Risk Reviews, Supplier Acceptance Forms, Validation Trace Matrices.
- Provide daily reports, metrics and project status to management utilizing Microsoft Project, Concerto and burn down charts for Production and Process Controls Remediation.
- Responsible for product design reviews and transfer process. Drove supplier development by assisting them in developing problem solving control tools such as process mapping, FMEAs, Process Capability studies and Gage R&Rs.
- Worked with IQA department to update the inspection plans on various components, including First Article Inspections, identified and implemented internal controls to further downstream to detect failures in components. Documented and reviewed these determination of controls to show the compliance to FDA purchase controls regulations.
- Worked on new production chemistry lab launching project.
- Worked in the capacity of SME for P&PC group to assess the remediated products per the New Quality system documentation to certify the current inventory levels and release the parts and components as needed for the production use.
- Worked on a label remediation project. Identified and updated labels per new regulations, design input requirements. Worked with various suppliers and processed label material, color, ink changes within the quality system.
- Worked as Design Quality Validation Engineer for various design changes and production process changes following design control procedures for proper development and control of design plan, design documents and specifications, protocols, V&V as necessary.
Confidential, Traverese, MI
- Responsible for developing, implementing and updating quality procedures, work instructions, installation, operational and process (IQ, OQ & PQ) validation protocols and plans, ensuring regulatory compliance with cGMPs of all medical devices regulatory agencies (i.e. FDA and ISO).
- Developed validation and quality assurance documents including templates for validation related documentation such as Validation Protocols, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) from CSV Compliance's and regulatory requirements aspects.
- Created Product Risk Management profile, including Hazard Analysis (ISO 14971), DFMEA, PFMEA.
- Aspects of 21 CFR Part 11, GAMP, GxP’s (especially GDP’s), various approaches to testing (positive testing, negative testing) and good practices regarding objective evidence documentation were given importance during the training sessions.
- Reviewed Risk Assessment Documentation to check the areas with deficiency, reviewed Corrective and Preventive Action (CAPA) and drafting Remediation Plans for the project management approval after the GAP Analysis
- Performed risk evaluation and executed risk management activities for assigned new product development and validation projects.
- Conducted remediation for medical equipment in an ISO 13485, 21 CFR 820, cGMP environment.
- Experienced in IQ/OQ/PQ/TMV/Software Validation in manufacturing Support and maintain compliance with 21 CFR Parts 820, 805, ISO 13485 and MEDDEV pertaining to complaint handling and MDR reporting.
- Prepared Validation Master Plan (VMP)
- Perform data integrity audits for the GMP manufacturing site with GMP test Lab, assign necessary corrective actions and author final reports.
- Documentation of various stages of AERS validation lifecycle, in accordance with FDA CFR Part 11 regulations
- Technical Writing and Documentation for all aspects of AERS Computer System Validation Life Cycle, in accordance with FDA Regulations, particularly 21 CFR Part 11
- Provided status updates for the project as per the management requires