SUMMARY:

• 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.

TECHNICAL SKILLS:

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 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.

PROFESSIONAL EXPERIENCE:

Confidential - Minneapolis, MN

CSV/Validation Engineer

• 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.
• Strong documentation skills for writing and executing verifications per FDA regulatory requirements and under a Quality System design control process and procedure.
• 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.
• Remediated Design Verification and Validation inconsistencies of the Design changes.
• Implemented Design History File (DHF) Remediation using Design Control elements as per 21CFR 820 Regulations on disposable medical devices
• Followed Standard Operating Procedures (SOP).
• Worked on Oracle Pedigree & Serialization Manager (OPSM) is used to generate unique serials for all medical devices.
• Developed and executed protocols for package design, packaging processes validation and package shelf life testing. Reviewed the Design History Files (DHF). Hands on experience in DFMEA and PFMEA Analysis.
• Responsible for approval of design verification, validation plan, protocols and completion report for multiple projects.
• 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.
• Developed Operation Qualification (OQ) test scripts for TrackWise Change Management modules and CAPA system
• Performed ISO 13485 Quality System review and ISO 14971 Risk Management audit review of medical devices, IAW 21 CFR 820
• Workflows implemented included complaints, CAPA and Change Control
• Understanding of FDA guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements.

Confidential, Chicago, IL

CSV/Validation Engineer

Responsibilities:

• Implementing Remediation actions on Gaps found after the completion of Periodic Validation Reviews (PVR) Reports for Medical Device Manufacturing Equipment, Manufacturing Processes, Product Sterilization Processes, Utilities and Facilities used for the manufacture of Eye care products such as Contact Lenses, Eye Fluids and Packaging.
• Monitored and Executed Cleaning Validation exercises on different stage of the manufacturing process (Blending, Compression, Coating and Inspections) for solid dosage.
• 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

Validation Engineer

• An aggressive customer timeline quickly added additional responsibility and accountability that required assistance in expertise relating to work activities for design and development of semi-automatic equipment, manual operations and on-line Inspection Systems for use in the manufacture of an implantable device and a multitude of medical device component products for delivery and extraction systems.
• 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.
• Evaluated design and processes to determine suitability for manufacturing, followed by R&R analyses.
• 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.

Confidential, Malvern, PA

Validation Engineer

Responsibilities:

• Reviewed existing Standard Operating Procedures (SOP’s) for System Administration.
• Change control Procedure and Testing SOP’s.
• Gathered User Requirements from Business process owners.
• Reviewed URS (User Requirements Specification).
• Ensured process and product quality during the processing steps of solid dosage manufacture, such as weighing, granulation, coating, drying, compression, and encapsulation.
• Reviewed FRS (Functional Requirements Specification) document and DS (Design Specification) documents.
• Analyzed and reviewed validation deliverables like Validation Plan, Risk Assessment, Quality Assurance review, Validation Summary Report in compliance with GxP FDA Compliance Regulations.
• Was involved in reviewing Corrective Action and Preventive Action (CAPA) documentation.
• Validated the Integration of the CAPA Workflow with the other business workflows and the interfaces for the TrackWise workflow.
• Developed Test Cases for Functional and Regression Testing.
• Took part in weekly status meetings with Project leads, team leads and subject matter experts to update work progress.
• Worked with MS Visio to create workflow models and process flow models after reviewing URS and FRS.