SUMMARY:

• As a Quality Engineer/Computer System Validation Consultant 5 years industry experience in highly regulated environment (FDA Part 11, 58, 210, 211, 820, GLP, GCP, GMP, and GAMP 5),centered on compliance and delivery of high quality risk assessment, design implementation, validation and maintenance solutions.
• Experience in generating all validation documents, including validation plan, Gap Analysis, Remediation Plan, URS, FRS, FAT, PFMEA, Risk Assessment, Design Specifications, IQ, OQ, and PQ Test Protocols, Traceability Matrices, Test Method Validation, DOEs, Standard Operating Procedures (SOPs), and Validation Summary Reports.
• Reviewed and Validated Computer Systems in compliance to 21 CFR Part 11 and QSR 820
• Experience in Computer System Validation in both Implementation and change control of Standard, Configurable COTS and Custom developed Systems
• Experience in planning and execution of Validation Master Plan (VMP), specifying requirements (URS/ FRS), Design Specifications (DS), creating protocols - Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), creating Requirements Traceability Matrix ( Confidential ), and writing Validation Summary Report (VSR).
• Has participated in various training to update the latest Confidential Device technology
• Experience in documenting all phases of system life cycle as required by FDA regulations.
• Strong experience in implementation of Change Management/Control and Corrective Action and Preventive Action (CAPA) procedures.
• Own and execute assigned NCR, SNCR and Developed Test method validation protocols (TMV). cGMP/GDP/GLP Compliance ISO 9001, 13485, 21 CFR 820,Experienced in maintenance of Electronic Records and Signatures and their restricted access
• Deep understanding of GxPs including GCP, GMP, GLP and GAMP 5 and their proper implementation
• Working knowledge of the industry standards like ISO 9000, ISO 9001, ISO 13485/14971
• Ability to work in a multidisciplinary team and problem solving skills.
• Impressive Analytical, interpersonal and communication skills.

TECHNICAL SKILLS:

Validation: FDA Quality system regulations, 21 CFR Part 11 (210, 211, 50, 820), protocols (IQ,OQ,PQ) cGXP (GLP, GMP) and ISO 13485, Standard Operation Procedures (SOP), DOE, SPC, FMEA, MSA, MES, ERES, Trackwise, Gap Analysis, Confidential, Audit Trials, Remediation.

Operating Systems: Windows XP/2007/Vista

Testing Tools: HP Quality Center, Test Director, Quick Test Professional, JUnit, NGMock

Languages: C, C+, SQL

Other Tools: MS Office (Word, Excel, Power point, Access), MS Visio, MS Project, Documentum, SharePoint, Outlook

Applications: AERS, Register, EDMS, Change Control, ChemStation

PROFESSIONAL EXPERIENCE:

Validation Analyst

Confidential, Pasadena,CA

Responsibilities:

• 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 Confidential 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.
• 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
• Reviewed nonconformance reports (NCR) and ensured appropriated product containment and disposition.
• Conducted remediation for Confidential 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.
• 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
• Implemented GxP (GMP, GLP) and GAMP guidelines in the systems.

Quality Assurance Engineer

Confidential, Frostburg,MD

Responsibilities:

• Performed design verification pertaining to device for risk management.
• Responsible for providing Software Quality Assurance (SQA) engineering support for all lifecycle phases of computerized systems that include MES, TRS and PDM.
• Performed ERES Assessment, developed Validation Master Plan (VMP) for the SAP implementations.
• Conducted Qualification and Validation reviews, High Level Risk Assessments, Electronic Records Electronic Signature assessments for CSV systems.
• Performed Detailed Risk Assessment by Failure Mode Effects Analysis (FMEA) for managing the risk levels used before validating the system.
• Involved in all activities in SDLC life cycle.
• Used Quality Center (HPQC) for drafting, pre-approving, testing and logging defects.
• Involved in defect development life cycle (HPQC) and assigned the created defects to developers. Once the defect is fixed, Retested the defect and it moved to the closed status.
• Updated the following validation deliverables for projects - Issues Log, Incident Reports, IQ Protocol/Report, OQ Protocol/Report and Trace Matrix

Confidential

Validation Analyst

Responsibilities:

• 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.
• 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.
• 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.
• Preparing a Data Migration Summary Report stating the data migration activities taken place while loading the static data in the LIMS application.
• Involved in preparation and documentation for all aspects of the computer system validation to ensure compliance in accordance with cGxp (cGMP, cGLP and cGCP) and FDA rules and regulations
• Drafting the Requirement Traceability Matrix document to track the URS and FRS are fulfilled by executing the OQ and PQ scripts.
• Developed & proposed a Quality Agreement standards & template for suppliers & sites for validation & data integrity.
• Developed and maintained IQ, OQ, PQ protocols for equipments like HPLC, GC, MS, Autoclaves, Freezers, Refrigerators, and other analytical laboratory equipment.
• Coordinated with the quality assurance team in updating and maintaining the SOPs for laboratory equipment.
• Sustaining Change Control support - Write and execute C&Q protocols on Autoclaves, Incubators, Depyro Ovens, Temperature Mapping

Confidential

Validation Engineer/Intern

Responsibilities:

• Provide proper Validation Rationale and Methodology input which brought department up to date on all cGMP training requirements.
• Responsible for performing quality reviews of CSV deliverables (validation strategy documents, validation protocols, traceability matrices, & summary reports) in support of a Consent Decree remediation project in a waterfall environment for a pharmaceutical manufacturer.
• This scope includes QC Instruments (both portable and computer-controlled), paper-based systems, and local instances of enterprise system data management.
• Performed Computer System Validation Risk Assessments
• Responsible for the review and approval of all Validation Protocols related to equipment, systems, utilities, sterilization, cleaning, computer and aseptic processes.
• Developed Protocol for transfer Pumps and performed the dry run to qualify the pumps. Developed and Updated the SOP for the Hibar Filler & Press equipment modifications.
• Pre-approve test sets and post-approve test runs for Batch Records ( Confidential ) in HP Quality Center.