SUMMARY:

• A bright, honest and quality - oriented healthcare professional with over 6 years of experience in the Pharmaceutical, Biotech, Drug and Medical Device manufacturing industries. Detail oriented professional with strong work ethic who carries a special expertise in Computer System Validation working on SAP, Trackwise, LIMS, ERP, CTMS. Highly skilled in planning, implementation, software development, testing, validation, quality control and System Development Life Cycle of a project with major emphasis on quality regulations as governed by the FDA, DEA and EMA. Initiative, independent and good communication skills. Strong leadership skills while possessing a great team spirit.
• Excellent knowledge of Software Development Life Cycle, Validation planning, IQ/OQ/PQ, RTM, validation reports, SOPs, GAMP 5, ISPE regulations, 21 CFR part 10 and 11, testing and deployment of a project.
• Efficient in interpreting regulatory standards: USFDA guidelines, International Council of Harmonization (ICH) guidelines, Quality System regulations, 21 CFR compliance, GAMP, and GxPs (GMP, GLP, GCP).
• Proficient in meeting the 21 CFR Part11and EUANNEX11requirements.
• Strong experience and academic in quality statistical analysis, quality improvements, CSV, strategic planning and compliance (21 CFR Part 11, 210, 211 and 820).
• Professional experience in GXP (GMP, GLP, GCP), 21 CFR Part 11, GAMP5 for Pharmaceutical/Biotech manufacturing.
• Experienced in documenting and managing the flow of information in the labs using BIOVIA workbook (e-lab notebook).
• Well proficient in maintaining audit trail for all the instruments, equipment and software projects to fulfil the regulatory requirements.
• Experienced in drafting proposals for the IT projects of pharma.
• 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 validating wide variety of applications like SAP ERP, Labware LIMS and CTMS.
• Experienced in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance with FDA rules and regulations.
• Academically trained in dealing with large dataset, tabulating the lab data, and report writing.
• Full validation life cycle experience including developing and maintaining SDLC for validated systems, Validation plans, IQ/OQ/PQ/RTM, and validation summary reports (VSR).
• Excellent knowledge of GAP analysis in identifying compliance gaps, corrective and preventive action plans (CAPA).
• Well versed with Risk assessment techniques, Regulatory assessment, Technical assessment, Remediation Plan and Deviation reports for FDA regulated environment.
• Excellent coordination skills with project managers, creating, managing and scheduling closely with them, working on documents related to the project lifecycle.
• Hands-on experience in using tools like HP-QC/ALM.
• Guided the IT teams on Good Documentation Procedures related to cGMP and other regulatory requirements.
• Designed testing protocols in white box, black box, integration and user acceptance testing.
• Knowledgeable about HVAC components like the furnace, heat exchanger, evaporator coil, condensing unit, ductwork, heat pump especially in to clean environment of pharma labs.
• Good technical writing capabilities.
• Good knowledge of HIPAA guidelines in terms to pharmaceutical sector.
• Understanding of SDLC and related methods of program development such as Waterfall, Agile, Prototype, Incremental, Spiral, Scrum method (including the Scrum meetings and techniques).
• Dedicated team player and a person with ability plus flexibility.
• Excellent written and technical writing skills.
• Strong presentation, verbal and written communication skills.
• Work well with a multi-cultural and diverse workforce.
• Willing to learn more as I progress in my career.

TECHNICAL SKILLS:

Validation: 21 CFR Part 11 (electronic records and signatures) (cGMPs), 803 (Medical Device Reporting), 820 (Quality System Regulation), Annex 11, European MDD, Canadian MDR, ISO13485, GAMP, Audit Trails, Standard Operating Procedures (SOPs), GAP analysis and Remediation, Validation Plan and Protocols, RTM, Risk analysis

Methodologies: Waterfall, Agile, Prototype, Incremental, Spiral, SCRUM, V-model

Analytics: HPLC, UV-VIS Spectroscopy, IR Spectroscopy, Autoclave

Tools: Programming logic controller (PLC), HP Quality Center, MS Office Suite, MS Visio, MS Project, Trackwise, BIOVIA Workbook, Empower 3 for HPLC validation

Operating Systems: Windows 2012/XP, Macintosh OS, UNIX

Language and Business tools: SAS studio, IBM SPSS, SQL, R, Visual Basics, Oracle EBS, SAP, ERP, CRM, EDMS platforms, Crystal reports (SAP), LIMS

Biotechnological tools: ELISA, PCR, Spectrophotometry, Compressed Air and Nitrogen systems, Tissue culture, Bacteriological and Viral isolation

PROFESSIONAL EXPERIENCE:

Confidential, Denville, NJ

Quality & Validation analyst

Responsibilities:

• 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 Confidential ’s Quality Management System and GxP regulations.
• Developed and managed multiple ERP implementation plans from initiation to closure.
• Conducted risk assessment, baseline reporting and GxP impact assessments of computer systems
• Risk assessment done - at Initial System level and at component level (HAZOP, FMEA, FTA).
• Documented user requirements and analyzed them if they had any impact on Confidential t safety or data integrity according to GAMP guidelines.
• Created validation plans and Validation Summary Reports (VSRs).
• Conducted User Acceptance Testing (UAT).
• Documented change control requirements and activities.
• Created user guides and conducted for computer systems.
• Performed QC data review for batch record in-process and final QC approval.
• Aided in troubleshooting and impact assessment for atypical conditions during validation runs.
• Ensured continued compliance to 21 CFR part 10 and 11 of the FDA.
• Managed document change request process for controlled documents (i.e. SOPs, Policies, Validation documents etc.)
• Reviewed all the SOPs regularly to address audit findings and integrate new operational processes.
• Participated in Internal audit program, external and regulatory audits.
• Planned and implemented department action plans based on internal and external audits, CAPA.
• Evaluated changes and managed revalidation and change control activities as needed.
• Ensured adherence by staff to quality, regulatory and GxP standards.
• Authored the deliverables - Validation Plan (VP), Requirement Specifications, Test Plan and Protocol, Requirement Traceability Matrix (RTM) and Validation Summary Report (VSR).
• Developed and maintained strong working relationships across all parts of the firm to facilitate timely and effective communication.
• Ensured that the project team follows all the quality assurance processes set by Confidential .

Confidential, Greensboro, NC

Validation Engineer

Responsibilities:

• Assisted the Director, QA to develop and analyze information and product specifications to determine standards and policies in the following areas: FDA, DEA regulations and other product regulatory requirements.
• Implemented remediation actions on gaps found after the completion of Periodic Validation Reviews (PVR).
• Monitored and executed cleaning validation exercises on different stages of the manufacturing process (Blending, Compression, Coating and Inspections) for solid dosage.
• Assisted in cleaning validation activities of swab sampling using TOC analyzer (by Shimadzu Scientific).
• Managed the audit process to monitor quality system and compliance with regulatory and customer requirements.
• Worked with Clinical Force (a pioneer in providing SaaS-based Clinical Trial Management system) for scaling production and efficiency.
• Performed Periodic Review on Ab Initio (Data Warehousing tool), SAS Tool, Excel Spreadsheets, Spectrophotometers, Particle Size Analyzers, HVAC systems for clean labs in accordance to cGMP standards.
• Worked in concurrence with FDA compliance in a highly regulated environment for all the aspects of CSV.
• Involved in reviewing Corrective and Preventive Action (CAPA) and drafting Remediation plans for the project management approval after GAP analysis.
• Loaded IQ, OQ, PQ into PDM (Product Data Management) system, a controlled document management system for review and approval signatures.
• Involved in all aspects of CSV lifecycle, to comply with FDA regulations (21 CFR Part 11).
• Conducted risk assessment for automated manufacturing equipment, computer systems and process systems as it related to 21 CFR part 11.
• Acted as validation SME for CSV activities performed by functional areas (analytical laboratory, manufacturing).
• Prepared detailed SOPs for IQ and PQ for validating autoclaves and HPLC (using Empower 3), giving higher detailing on Filter sterilization, saturated steam checks including vendor specifications.
• Wrote and executed validation documents following SDLC process.
• Participated in quality deviation/ change control program (TrackWise).
• Monitored the testing (white box, black box, integration) conducted by QA department and documented into the Validation Summary reports.
• Helped with procurement support, mentoring, and contractor oversight

Confidential, San Jose, CA

Validation Engineer

Responsibilities:

• Analyzed user requirements document, system specification document.
• Developed, implemented and executed test methodologies and plans to ensure software product quality.
• Created test plan and detailed test cases using Quality center.
• Tracked changes made to the requirements, tests and defects using Quality center.
• Assisted in development and maintenance of regulatory rules to ensure compliance with US FDA 21 CFR 820, ISO 13485, European MDD.
• Assisted in manufacturing by developing process descriptions, maintenance procedures.
• Created documents to comply with the appropriate FDA regulations including 21 CFR Part 11 requirements.
• Worked on Traceability Matrix.
• Tracked defects while testing and reporting using HP Quality Center and manual testing.
• Created and reviewed IQ, OQ, PQ protocols, Master Validation Plan.
• Involved in GAP analysis for user requirements verification and devised remediation plan.
• Performed Data Migration Policy.
• Coordinated the activities in the SDLC with focus on the system analysis and maintenance activities.
• Developed Test plans that contained test scripts, test cases, test data and expected results for User-Acceptance testing.
• Technical involvement with projects, support during audits, and collaboration with the vendors.
• Wrote and executed test cases to validate user requirements and exercise all system functions.
• Provided Validation strategy documents which involved project overview, development approach, roles and responsibilities, validation approach and deliverables.

Confidential

Validation & Quality control lead

Responsibilities:

• The project was based on validationof a Labware Laboratory Information Management System (LIMS) version 6 customized per the policies at BioXcel
• Responsible for writing Test cases, and Test scripts for the Lab Ware LIMS modules.
• Involved in preparing and updating IQ, OQ, and PQ Test plans.
• Conducted periodic evaluation to demonstrate that LIMS system remained in a validated state in its life cycle.
• DevelopedValidationSummary Report (VSR) to summarize allvalidationactivities.
• Reviewed completevalidationdocumentation to ensure actual results match expected results and all deviations that occur during thevalidationprocess are resolved appropriately.
• Involved in deviation investigations, SOP preparation and quality system development, and equipment qualification.
• Completed a flowchart for Sample Manager and Labware LIMS to demonstrate appropriate workflow functionality.
• Provided to validate test associates based on Good Documentation Practices (GDP).
• Ensured requirements are met by completing a Requirement Traceability Matrix.
• Assured that allvalidationvariables follow the applicable SDLC methodologies.
• Reviewed Test scripts (IQ, OQ, PQ) and Standard Operating Procedures (SOPs) to be compliant with regulations.
• Drafted SOPs according to GMP and 21 CFR part 11 requirements.

Confidential

Jr. Validation Analyst

Responsibilities:

• Defined validation strategies for manufacturing facilities, packaging equipment, utilities, computer systems and laboratory instrumentation.
• Provided cleaning validation protocols, developed and defined cleaning acceptance criteria using industry standards.
• Collected and tabulated data and looked for errors, discrepancies and project results into final report.
• Generated risk assessment to discuss the approach to cleaning related activities.
• Authored test protocols for validating existing tests within the process, including Installation, Operational and Performance Qualification (IQ/OQ/PQ) protocol for manufacturing equipment.
• Participated in audits as process and quality systems subject matter expert.
• Performed root cause analysis and CAPA follow- ups.
• Complied with ISO standards and requirements.
• Interacted with Business owners, System owners, Business Analyst, and Technical writers.