SUMMARY:

• 8+ years of experience in Pharmaceutical Industry working as a Sr. Validation Analyst in Validating the Lab Ware LIMS V6, Watson LIMS, SQL LIMS, Electronic Document Management systems (EDMS), and Cleaning Validation with all the GCP, GLP, GMP and 21 CFR PART 11 Rules
• Experienced in performing System Testing and User Acceptance testing (UAT) for various software applications that are used in Pharmaceutical business processes in GMP, GLP, and GCP environment
• Experience in validating and testing computer systems that comply with FDA regulations 21 CFR Part 11, Part 210, 211 and QSR 820
• Experienced in generating both procedural (SOPs, Work Instructions, user manuals, admin guide etc) and quality system (user requirements, functional requirements, validation plan, Test plan etc) documentation to ensure that they comply with FDA regulations and company policies.
• Experienced in generating the validation deliverables at each phase of SDLC including, but not limited to Validation Master Plan (VMP), Validation Plan (VP), User Requirements Specification (URS), Functional Requirements Specification (FRS), Software Design Specification (SDS), Installation qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Traceability Matrix (TM), and Validation summary report (VSR)
• Experience in working with Document Management Systems such as Electronic Document Management System (EDMS), Epic Star, Documentum, Share Point, and Val Genesis (Validation Management System)
• Experience in performing 21 CFR Part 11, Risk assessment, Gap Analysis and performing internal audits for various software applications and systems that are used in Pharmaceutical companies
• Thorough knowledge of all FDA regulations including Prescription Drug Marketing Act (PDMA)

TECHNICAL SKILLS:

Programming Languages: C, C++, Visual basic, and SQL

Database: Oracle 8i/9i, SQL Server. MS Access

Languages: SQL, PL/SQL, C, C++, Shell Programming (bash), XML

Networking: Microsoft Windows NT/2000, IIS, FTP and Novell.

Validation: Lab Ware LIMS V6 (IQ/OQ/PQ) Protocols, FDA Regulations, 21 CFR Part 11/58/210/211/820, GAP Analysis, GxP (cGMP, GCP, GLP, GDP), VMP, RTM, SOP, Summary Reports, Audit Trails, SQL LIMS, Watson LIMS, ISO 13485/14971/60812

Testing Tools: Test Director7.0, Win Runner7.5, LoadRunner7.0

Operating Systems: Microsoft Windows XP/9x/NT/2000, and Mac OS

Office Tools: MS Office, MS Excel, MS PowerPoint.

Project Management: MS - Visio, MS Project.

Technologies: Rational Unified Process (RUP), OO Design, Data ModelingBusiness Modeling

Process/Model tools: Rational Rose, RequisitePro, MS Visio,and Erwin, TOAD

PROFESSIONAL EXPERIENCE:

Confidential, Chalfont, PA

Sr. Validation Analyst

Responsibilities:

• Performed Gap Analysis to obtain sufficient information for Lab Ware LIMS V6 (Requirements, H/W, S/W, SOPS, 21 CFR 11 Criteria and new interfaces, if any)
• Prepared Remedy plans in case the system fails (Requirements, H/W, S/W, SOPS, 21 CFR 11 Criteria, interface information)
• Involved in writing and executing IQ, OQ and PQ protocols for the Lab Ware LIMS V6
• Used 21 CFR Part 11 and GxP guidelines to verify system compliance with the FDA regulations
• Developed and maintained the Requirements Traceability Matrix to track requirements during the QA Testing Phase
• Prepared validation plans, functional requirements and specifications
• Developed test cases and test scripts to perform functional testing and for the security and database maintenance of the system
• Developed procedures for describing the in-process controls and tests
• Extensive experience in drafting LIMS User Manuals for Stability, Lot Management, Environmental Monitoring, Inventory Management, and Reports modules

Environment: Used: Windows XP, Oracle 8i, Citrix, Rational Suite, Lab Ware LIMS V6, COGNOS, Informatica Power Play and Power Mart

Confidential, Chestebrook, PA

Sr. Validation Consultant

Responsibilities:

• Prepared Change Control Procedures for existing Lab Ware LIMS V6 systems
• Performed IQ, OQ and PQ and wrote test scripts and cases, SOPs, recorded, reviewed and verified the results.
• Developed Validation Plans, Validation Summary Reports, Gap analysis, Functional and Requirements specifications with the help of Business analysts, project managers and IT department members
• Ensured that all parts of the system are in compliance with the FDA regulations, 21 CFR part 11, which deals with the maintenances of Electronic Records and Signatures. The manufacturing procedures are also made to comply with the FDA regulations, 21 CFR parts 210 and 211
• Created folders and user account credentials and stored them on Windows 2000 server
• Discussed with the Change Control Committee, for any changes to be made and prepared Change Request Forms accordingly
• Performed frequent FDA auditing and completed QA checkpoints successfully

Environment: Used: Windows XP, Oracle 10g, LIMS, MCAS, UNIX, SAS, Citrix, Reflections for Web FTP, Documentum, MS Visio2006.

Confidential, Wilmington, DE

Sr. Validation Consultant

Responsibilities:

• Ensured Data Migration compliance with LIMS
• Developed Templates of Standard Operating Procedure SOPs of the company for documenting Validation Plan, Test Cases and Test Procedure based on Business Requirements
• Designed and wrote manual templates, design formatting, project planning and proofing documents.
• Conducted tests on technical features of LIMS and documented its usability.
• Wrote test specifications, testing methodologies and user manuals for LIMS
• Designed and maintained Standard Operating Procedures (SOPs).
• Wrote documentation for computer validation life cycle and Validation plan and protocol in accordance with FDA regulations
• Developed and executed development, regression, integration and validation protocols for Watson’s LIMS.
• Monitored the testing conducted by QA dept and documented the Validation Summary Report
• Assisted the QA team in updating the Validation Plan
• Coordinated with System Analyst, Project Manager, and Business Analyst to setup the pre-validation and Validation environment to execute the scripts.
• Made deviation investigations, SOP and quality system development, and documentation control and equipment/facility qualification.
• 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.

Environment: s: Watson’s LIMS, Oracle 9i, MS Office 2004, MS Visio 2004

Confidential, Souderton, PA

Validation Consultant

Responsibilities:

• Validated analytical laboratory equipments such as GC, HPLC, Autoclaves and Incubators in compliance with FDA regulations.
• Involved in validating computer system interface with laboratory equipments such as Spectrophotometer, HPLC, GC and Autoclave
• Customized and validated different components of the LIMS modules
• Acquired and documented the business requirements
• Prepared Validation Master Plan (VMP) for validating analytical laboratory equipments and LIMS.
• Hands on experience in formulating Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) for validating
• Executed IQs, OQs and PQs to check the functionality of the system
• Generated Validation Summary Report to summarize and document all validation activities
• Developed and reviewed Standard Operating Procedures (SOPs) for various functionalities of the system
• Validated and used Empower Chromatography Data Software by Waters
• Created presentation slideshows and provided to all testers to ensure all company standards are followed during test execution.
• Served as point of contact in the absence of supervisor.
• Analyzed test scripts to check whether all functionalities have been covered within the compliance of 21 CFR Part 11
• Responsible for ensuring the compliance of GMP/GLP and FDA regulations
• Maintained the quality of all project deliverables despite extremely aggressive timelines.
• Handled multiple projects and change requests simultaneously without compromising project schedules.
• Assisted in generating the Error Report Form and resolving the errors encountered during the testing effort and maintained the Error logs for the errors.
• Involved in creating Statement of Work (SOW), revision to the existing SOP’s and establishment of internal company standards.
• Assisted in development of validation/systems compliance on systems compliance initiatives; provided continuing compliance support to the Global IT Organization.
• Conducted internal and external reviews, as well as, formal walkthroughs, and participated in status meeting.

Environment: s: Windows Server 2003, SQL LIMS, QTP, MS Office 2003, Empower Chromatography Data software by Waters

Confidential, North Wales, PA

Validation Analyst

Responsibilities:

• Involved in Retrospective Validation of Electronic Document Management System (EDMS)
• Involved in all the phases of SDLC right from gathering User requirements to protocol testing phase.
• Involved in review, and development of Functional Requirement Specification( FRS) and User Requirement Specification( URS), Validation plan, and Traceability Matrix
• Engaged in reviewing Part 11 and CSV Assessment and reviewed mitigation strategies
• Written, Revised and updated protocols of IQ/ OQ/ PQ for Documentum 4i.
• Performed Unit Testing (UT), Integration Testing (IT) and User Acceptance Testing (UAT) to ensure Compliance of the System.
• Responsible for documenting Test Plans, Test Cases, Test Scripts, User Manuals, technical and installation guides.
• Thorough knowledge of corporate quality standards

Confidential, San Francisco, CA

Validation Engineer

Responsibilities:

• Wrote the Validation Master Plan and all validation related SOPs for a new department of commercial operations.
• Tracked and scheduled validation activities for all departments through weekly meetings, wrote validation status reports/schedules and maintained validation electronic file archive.
• Initiated CAPA actions and Change Requests in response to internal quality audits and procedures.
• Performed on the operation of equipment used by the manufacturing and quality functions.
• Managed two direct reports in validation and calibration.
• Supervised execution of protocols at contract Filling/Packaging site. Submitted reports to the FDA concerning changes made to the contractor's filling equipment.
• Performed gap analysis with current procedures against corporate guidelines. Assessed compliance with requirements of 21CFR part 11, EU, ICH, GAMP, ASTM, NIST, USP and ISO guidelines, and cGMP procedures.
• Supervised engineers in the execution of validation protocols and completion of turnover packages.
• Wrote validation protocols, final reports, and performed cleaning validations and hold time studies of fermentation equipment, validation of databases to GAMP guidelines, and validation of all facilities, major and analytical equipment.

Confidential

Validation specialist

Responsibilities:

• Developed Installation, Operational and Performance Qualification (IQ, OQ and PQ) Protocols for equipment (Incubator, Freezer and Autoclave).
• Perform sterilization studies for autoclaves and depryogenation ovens, sterilization in place (SIP) and/or cleaning in place (CIP) studies for skids, glass washers.
• Performed swab test for cleaning evaluation along with quantitative & qualitative analysis, MACO (Maximum allowable carryover) limit calculation for change over.
• Conducted executions of Protocols, change controls, Test Scripts and UATs.
• Prepared Deviation Reports when the test criteria did not meet the acceptance criteria.
• Supervised Compression and Coating of tablets as per BMR (Batch Manufacturing Record) following SOPs.
• Conducted experiments to produce in-process data along with batch production such as dissolution, disintegration, friability, and hardness.
• Track and communicate progress of team assignments and milestones