OBJECTIVE

• Seeking a challenging career with a progressive organization, which will utilize my skills, abilities and education.

SUMMARY

• 12+ years of diversified experience in Validation Lead, Quality Assurance, Business Analyst, Project Management and Technical Writing.
• Good knowledge of the components of Software Development Lifecycle (SDLC) and System Validation Lifecycle (SVLC).
• Expertise in various regulations such as FDA, ICH, MHRA, HIPPA, EMEA, MHLW, SOX, EU regulations, Annex 11, JSOX, ISO, etc.
• Good understanding of IDMP standards for Regulatory Affairs.
• Experience of validating lab equipments, processes, and software systems.
• Expertise in documenting URS, FDS, MDS, Test Plan, RTM; well versed with FDA 21 CFR Part 11: Electronic Forms, Electronic Signatures and Audit Trails.
• Expertise in 21 CFR Part 820 / 211 regulations and ISO 13485.
• Good Knowledge of Validation practices in strict cGMP, cGLP, and cGCP environments for pharmaceutical industries.
• Good understanding of best practices in pharmaceutical and chemical industries.
• Experience encompassing Software, Equipment and Process Validation.
• Good understanding of ISO 9000, GAMP 4.0/5.0 and FDA guidelines for pharmaceutical industries.
• Good understanding of Labware, Watson and SQL*LIMS.
• Good understanding of SAP and SAS.
• Good understanding of ITIL concept and practices.
• Involved in Project Management and of various projects, maintain timelines, business system management, outsource services, vendor, migration, mergers, acquisitions, etc.
• Involved in Manual and Automated Testing of applications developed on Windows and UNIX Environment.
• Experience in writing, maintaining and updating Test Documentation for various stages of testing for reference and Auditing purposes.
• Good knowledge, hands on experience and trained lab technicians on analytical instruments like GC/MS, HPLC, UV - VIS, FTIR, SEM and spectrophotometer.

TECHNICAL SKILLS

Testing Tools: WinRunner, Load Runner, Quality Center

Test Reporting Tools: Test Director

Languages: SQL, C

Operating System: Windows NT/2000/2003/XP/7, UNIX

Databases: SQL Server, MS - Access, Oracle

Applications: MS Office, MS Visio, Adobe PDF writer, Reference Manager, End Note, SAS, First Doc - Documentum (SaaS application), HYSIS, Chrom Perfect, Empower, Chem Station, Omnic, Anawin, Watview, Maple, Matlab, Winrunner, Load Runner, Quick Test Pro (QTP), HP Quality Center, Trackwise, ARISg, CTMS (Clinical Trial Management System), SAP.

LIMS: SQL*LIMS, Labware LIMS, Watson LIMS

PROFESSIONAL EXPERIENCE

Confidential, Piscataway, NJ

Sr. Quality and CSV Lead

Responsibilities:

• Maintain validation project timelines / scorecards, etc.
• Reviewed and approved Compliance Analysis (CA), Validation Plan, User Requirement Specification (URS), Functional Requirement Specification (FRS), Technical Design Specifications (TDS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Regression Testing (RT), Positive / Negative test scripts / test cases / protocols.
• Coordinated and performed Quality Review of validation documents.
• Reviewed and approved Traceability Matrix to track all the user and function requirements to the corresponding testing.
• Maintain and keep track of Change Controls.
• Reviewed and approved various Change Control forms such as Request for Change (RFC), Code Promotion Request (CPR)to QA / Prod and Change Report Form (CRF).
• Prepared Data Migration Plan, Data Migration Summary Report, Data Migration Protocol and documented Data Migration discrepancies and mitigation of any discrepancies.
• Reviewed and approved test cases (OQ, PQ and UAT) in HP Quality Center.
• Updated Inventory list for validation documents generated during Change Controls.
• Sent validation documents for archival.
• Managed team of 3 members in onshore/offshore model.

Environment: Share Point, Snagit, Visio, MS Project, HPQC.

Confidential, Woodcliff Lake, NJ

Sr. Validation Analyst

Responsibilities:

• Maintain validation project timelines / scorecards, vendors, quality, risk assessment and management, troubleshooting, etc.
• Documented Master Validation Plans, Data Migration, Configuration Specifications (CS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Regression Testing (RT), Positive / Negative test scripts / test cases / protocols, GxP Assessment Report, 21 CFR Part 11 Assessment Report.
• Develop Validation Approach for various COTS as well as in-house GxP applications.
• Develop Qualification Approach for various COTS as well as in-house non-GxP applications.
• Coordinated and performed Quality Review of validation packages from various vendors.
• Reviewed and analyzed the User Requirements and Functional Requirements and prepared Validation Master Plan.
• Develop Traceability Matrix to track all the user and function requirements to the corresponding testing.
• Maintain and keep track of Change Controls (part of in-house developed Change Management system) in Lotus Notes database.
• Prepare Data Migration Plan, Data Migration Summary Report, review TRU Migrate and TRU Compare logs for data migration discrepancies and mitigate any discrepancies.

Environment: Share Point, Snagit, Visio, First Doc -Documentum, MS Project, First Doc, HPQC, HP ALM.

Confidential, Franklin Lakes, NJ

Validation / Quality Assurance Lead

Responsibilities:

• Independently managed various SAP process teams such as ATR (Acquire to Retire), DTS (Demand to Supply) - Make, DTS (Demand to Supply) - Plan.
• Managed group of 4 validation resources for supporting various SAP process teams
• Documented Master Validation Plans, Configuration Specifications, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Test Summary Reports, Risk Assessment Report, 21 CFR Part 11 Assessment, CSV Assessment, Training Plans, etc.
• Developed response, approach and Project Plan for Audit Remediation.
• Reviewed and approved URS, SRS and SDS documents
• Reviewed and approved manual and automated HPQC / ALM test cases (IQ, OQ and PQ).
• Trained end users on GDTP (Good Documentation and Testing Practices).
• Managed program and project level project plans.
• Perform internal audits for business and IT processes.
• Perform external audits for several vendors.
• Prepared project status reports for PM meetings.
• Coordinated with business teams for UAT testing.
• Develop Traceability Matrix to track all the user and function requirements to the corresponding testing.
• Performed end-to-end testing for integrated systems.
• Updated procedural (SOP, WI, etc.) documents.

Environment: HP Quality Center, HP ALM, Share Point, Snagit, Visio, Documentum, MS Project.

Confidential, Rahway, NJ

Manager, Validation / Testing

Responsibilities:

• Independently managed various clinical projects.
• Documented Master Validation Plans, Configuration Specifications, Installation Qualification (IQ), Functional Verification (FV), System Integration Testing (SIT), Summary Reports, Positive / Negative test scripts / test cases.
• Managed team of 10 members in onshore/offshore model.
• Managed program and project level project plans.
• Prepared project status reports for PMO meetings.
• Coordinated with business teams for UAT testing.
• Followed 3 different SDLCs (i.e.: Legacy Schering Plough, Legacy Confidential and New Confidential ) and several SOPs for validating systems.
• Tested database tables, Views, Procedures and Materialized Views as per requirements.
• Evaluated SQL queries with developers and solution architects for testing various Oracle and Seibel databases.
• Develop Traceability Matrix to track all the user and function requirements to the corresponding testing.
• Performed end-to-end testing for inbound and outbound systems.

Environment: HP Quality Center, Share Point, Snagit, Visio, Seibel CRM, Oracle database repository, First Doc, MS Project, TOAD.

Confidential, Woodcliff Lake, NJ

Sr. Validation Analyst

Responsibilities:

• Independently managed and successfully completed implementation of various clinical projects like EDC, Viewpoint, TableTrans, PDxPop, Winnonlin, LMS, etc.
• Maintain project timelines / scorecards, resources, licenses, vendor contracts, SLAs, budgets, quality, risk assessment and management, outsource applications, troubleshooting, etc.
• Documented Master Validation Plans, Configuration Specifications, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Regression Testing (RT), Positive / Negative test scripts / test cases / protocols.
• Develop Validation Approach for various COTS as well as in-house GxP applications.
• Develop Qualification Approach for various COTS as well as in-house non-GxP applications.
• Coordinated and performed Quality Review of validation packages from various vendors.
• Prepared and updated Standard Working Practice and SOPs to remediate CQA Internal Audit Findings.
• Reviewed and analyzed the User Requirements and Functional Requirements and prepared Validation Master Plan.
• Develop Traceability Matrix to track all the user and function requirements to the corresponding testing.
• Maintain and keep track of Change Controls.
• Perform end-to-end testing for in-house developed change control database.
• Develop Data Migration Plan for data migration of various applications.
• Develop GxP Assessment Reports for various applications.
• Developed 21 CFR Part 11 Assessment for various applications.
• Developed best practice for Good Documentation and Testing Practices (GDTP), scanning, archiving and assigning document identification numbers.
• Develop Risk Assessment Plan, Risk Assessment Report and develop Mitigation Plan.
• Developed and maintained Project Scorecards using MS Project, Primavera and Quickbase.
• Developed checklists and trained people to remediate findings in GAP Analysis.
• Wrote documentation for all aspects of the computer systems validation lifecycle, in accordance with FDA regulations, particularly CFR 21, part 11, including: Validation Plan and Protocol, Installation Qualification (IQ) Specification, Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification, User Acceptance Testing (UAT), Technical Architecture Document, User and Functional Requirement Specification, Validation Summary Report, etc..
• Develop and maintain Remediation Plan.
• Performed internal and external audits of departments.
• Performed CAPA Plans to mitigate audit findings.
• Expertise in usage of automated tools like WinRunner, Load Runner, HP Quality Center, etc.
• Developed templates for IQ, OQ, PQ, VP, URS, FRS, TDS / TAD, vendor assessment, risk assessment plan, risk assessment report, GxP assessment and VSR.
• Validated computer system using cGMP, cGLP and cGCP guidelines and company’s policies / guidelines.
• Develop and maintain Process Maps using MS Visio to represent the existing workflow.
• Developed checklists for Good Documentation Practices.
• Developed strategies for Business Continuity and Disaster Recovery.
• Develop and implement procedure for logical and physical security, periodic review, decommissioning and hardware disposal, backup and recovery.
• Developed several SOPs/Policies/Guidelines like Unified Change Control Procedure, Disaster Recovery, Periodic Review, Computer System Retirement, Physical and Logical Security, etc.
• Performed GAP Analysis during the SVLC and developed Remediation Plan.
• Good understanding of keeping system in validated state after validation.
• Reviewed and authored Qualification Plans, IOQ Protocols and Qualification Summary Reports.
• Conducted periodic internal audits to keep the department in compliance with company’s policies and FDA’s regulations.
• Developed transition procedure for outsourcing.
• Conducted Vendor Audits to check their compliance with company’s policies and requirements.

Environment: Lotus Notes, MS Office, MS Visio, eMaps, MS Project, Primavera, MS Project, Quickbase, Snagit, Citrix.

Confidential, Chicago, IL

Sr. CSV Engineer

Responsibilities:

• Reviewed the user requirements, wrote function specifications and prepared Validation Master Plan and Test Criteria.
• Wrote validation procedures, detailed reports for the existing status of the cGXP
• A member of assessment team to study the 21CFR part 11 requirements.
• Follow the Standard Operating Procedure SOPs of the company in documenting Test Plan, Test Cases and Test Procedure using Business requirements document and Functional requirements document of the system.
• Wrote 21CFR Part11 Assessment Plan for the application and supervised the Assessment Traceability.
• Coordinated with Project Manager(s) to write the Validation Master Plan.
• Verified Process Mapping to outline initial validation plan and process control strategy
• Coordinated with System Analyst to make the Server and Machines qualified through complete IQ/OQ procedures.
• Wrote the IQ & OQ for Oracle Database Server, Web Server (IIS), Application Server (Cold Fusion) and Dynamic Host Configuration Protocol (DHCP) Server.
• Supervised and wrote the Test Scripts and analyzed Test Scripts to check if it has covered the functionalities, which need to be in compliance with 21CFR Part 11 rules set by FDA.
• Developed Traceability Matrix to track requirements during the QA Testing Phase.
• Maintained the Requirements Traceability Matrix (RTM).
• Executed scripts for the formal validation process with implementation of cGCP, cGMP, cGLP.
• Supervised the formal execution of IQ/OQ and Test Scripts.
• Drafted the Remediation Plan for the Project Management approval after Gap Analysis.
• Executing Black Box, Negative and Security Tests as per test plans and test scenarios.
• Reported and documented problems found during tests and communicated recorded problems to the responsible development personnel.

Environment: Oracle 9i Enterprise Edition, VB 5.0/ASP, UNIX and Windows 2000, SQL Plus