PROFESSIONAL SUMMARY:

• A bright, honest and quality - oriented healthcare professional with over 6 years of experience in the Pharmaceutical, Biotech, Drug and Device Manufacturing industries. Detail oriented professional with strong work ethic who carries a special expertise in Computer System Validation. Highly skilled in planning, implementation, software development, testing, validation 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 Part11 and EUANNEX 11requirements.
• 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.
• 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.
• Experienced in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance with FDA rules and regulations.
• 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
• 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.
• 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, 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

Tools: Quality Center, MS Office Suite, MS Visio, MS Project

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

Language and Business tools: SAS, IBM SPSS, SQL, Oracle EBS, SAP, ERP, CRM, EDMS platforms

Biotechnological tools: ELISA, PCR, Spectrophotometry, Tissue culture, Bacteriological and Viral isolation

PROFESSIONAL EXPERIENCE:

Confidential, Denville, NJ

Computer System 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.
• Planned and Executed all computer system validation projects.
• 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.
• 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.
• 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).

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.
• 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
• 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 and EU Annex 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, giving higher detailing on Filter sterilization, saturated steam checks including vendor specifications.
• Wrote and executed validation documents following SDLC process
• Monitored the testing (white box, black box, integration) conducted by QA department and documented into the Validation Summary reports.

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.
• Created documents to comply with the appropriate FDA regulations including 21 CFR Part 11 requirements.
• Worked on Traceability Matrix
• 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.
• 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 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.