SUMMARY

• Diversified 7+ Years of experience as a Validation professional in the pharmaceutical industry, known for the ability to develop and implement processes that positively impact the compliance results.
• Strong understanding of 21 CFR Part 11 drug GXP requirements including electronic records, electronic signatures, system validation strategies and documentation.
• Working experience in FDA regulated environment and research laboratories with good understanding of cGxP (cGMP, cGDP, cGLP) standards and Risk based validation.
• Configured changes including updates to global change control process.
• Competent in quality system and standard 21 CFR (part 11, 50, 58, 210, 211) and GAP Analysis.
• Good knowledge of Software Development Life Cycle (SDLC), familiar with Software Methodologies like Waterfall, Spiral, V - Model and Agile in relation to development and testing.
• Experience in reviewing and developing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA rules and regulation.
• Expertise in developing the validation protocols, executing tests, and construction of summary reports for IQs, OQs and PQs.
• Well versed with GAMP 4 & GAMP 5 guidelines.
• Experienced in drafting new SOPs & training users on SOPs for various systems.
• Expertise in preparing Risk Assessment, Remediation Plan and Deviation Reports for FDA regulated environment.
• Sound knowledge of clinical trial processes and clinical data management practices.
• Experience in reviewing Corrective and Preventive Actions (CAPA) and highlighting and suggesting the remediation plans to mitigate the non-compliance.
• Developed comprehensive Test Plans, Test scripts and Test Reports. Performed Regression, Black box, System and UAT testing using both HP Quality Center and paper based manual testing.
• Proficient in dealing with Change control management systems, Laboratory information management system (LIMS), Adverse event reporting system (Argus safety AERS), Enterprise document management system (EDMS).
• Hands on experience in tools like HP Quality Center, TRIM Context Dataset, and Documentum.
• Good experience with MS Visio in developing flow charts and flow diagrams.
• Excellent communication, writing and interpersonal skills and strong ability to perform as part individually and also as a part of team.

TECHNICAL SKILLS

Operating System: Windows2000/2003/XP/Vista, MS-DOS

Tools: MS Visio, MS Project, MS Office (Word, Excel, PowerPoint, Access)Documentum, and HP ALM, QUMAS, HP TRIM, LIMS, ELN AERS, Trackwise.

Regulations: FDA Quality system regulations, 21 CFR (part 11, 50, 58, 210, 211)GxP, IQ/ OQ/ PQ, Audit trails.

PROFESSIONAL EXPERIENCE

Confidential, Ca

Validation lead

Responsibilities:

• As a validation lead involved End to End Validation of many projects in IR (Information Research) department especially in LIMS and RQS (Regulatory, Quality and Safety) area.
• Worked on both quality and non-quality systems
• Experience in writing test scripts for complex requirement and reviewing them as a Validation Lead and testing some of them.
• Authored test scripts related to SLIMS and GLS (Global Labelling System) standalone applications.
• Worked on other non-quality AbbVie internal systems like GRIP and DQA
• Interacted with QA Engineers for Quality review of Validation Documents.
• As I have QA experience in my previous projects I do not have any comments on my scripts that I execute as part of testing.
• Authored and reviewed test cases related to Soltraqs (Trackwise) module.
• Experienced in testing of Lab Management applications like LIMS.
• Handled all the validation deliverables related the projects I am assigned for in AbbVie.
• Followed all the SOPs required to the standard procedures for change requests, DIET system, HPALM.
• Conducted the entire testing related to all applications using HPALM tool and resulted were also stored at same location.
• Proficient in using HPALM tool.
• Good working knowledge in DIET (Defect, Incident, Enhancements tracking tool) a change management system. (From opening to closing a DIET).
• Responsible for Authoring and reviewing Traceability matrix document, System Certification Summary documents.
• Sound knowledge in using SNOW ADAM which is now service now system.
• Used Service now system to route all the documents to review and approval.
• Provided technical writing abilities for developing controlled documents involved with new computer systems implementations, change controls and other deliverables of computer systems validation.

Confidential, NJ

Validation & QA Lead

Responsibilities:

• Responsible for technical writing support for IT Quality Management activities.
• As a document coordinator, organized, standardized and maintained workflow of documents for validation documentation structure including change controls.
• Provided technical writing abilities for developing controlled documents involved with new computer systems implementations, change controls and other deliverables of computer systems validation.
• Developed documentation to capture User Requirements, Functional Requirements, Design Documents, IQ/OQ/PQ Test Scripts, Validation Plans and Summary reports, system manuals, SOPs, etc. in an efficient manner.
• Support communication between the members of IT and other departments.
• Served as validation lead from Eisai client on TRACE project where the vendor is CSC (computer system corporations).
• Responsible for authoring Validation plan, summary report and system release memo for TRACE project.
• Part of TRACE project weekly meetings to finish the project in time and succeeded in achieving the time line.
• Reviewed all the documentation from CSC such as UFRS, IQ, OQ, PQ pre and post executed scripts.
• Responsible for authoring Validation Plan, Risk assessment plan, UFRS, UCT documents for InForm v5.5.3.
• Scheduled team meetings with System Owner and Quality manager to track the work flow of the documents related to InForm v5.5.3
• Reviewed documents related to ARISg, GCDMS, SRS, LMS, iSample, eCTDXPress, eDGE and many other ongoing projects within Eisai US, UK and Japan.

Confidential, NJ

Sr Validation Engineer

Responsibilities:

• Responsible for assisting in the implementation of software systems in conformance with regulatory requirements as they pertain to 21CFR part 11.
• Reviewed and modified existing Standard Operating Systems (SOPs) for Document management system, System Administration, Change Control Procedures and Testing SOPs.
• Worked as business analyst and with HP TRIM as a part of record management system.
• Responsible for analysis, maintenance and administration of process management systems and quality management solutions environment.
• Conducted Trackwise (Audit Module) testing using HPQC.
• Developed Traceability Matrix and Validation Summary Reports as part of Validation Deliverables.
• Analyzed the applicability of GxP Requirements, 21 CFR Part 11 Requirements for the computer systems.
• Developed Validation Deliverables based on the Computer System Validation SOP.
• Well versed with GAMP 4 & GAMP 5 guidelines.
• Developed protocols for unit/system test cases, scripts and plans.
• Conducted meetings with the team members to point out the deficiencies in requirements and suggested the ways to cover it.
• Authored and reviewed the following types of documents: User/ Functional Requirements, Technical Design Specifications, Validation protocols (IQ, OQ, PQ) and validation final reports.
• Responsible for coordinating with team members in locating, tracking, organizing and verifying validation documentation for cGMP compliance and regulatory requirements.
• Reviewed the User Requirements and prepared the detailed Test Plans and Test Criteria.

Confidential, CO

Sr. Validation Engineer/Technical writer

Responsibilities:

• Responsible for assisting in the implementation of software systems in conformance with regulatory requirements as they pertain to 21CFR part 11.
• Reviewed and modified existing Standard Operating Systems (SOPs) for Document management system, System Administration, Change Control Procedures and Testing SOPs.
• Responsible for analysis, maintenance and administration of process management systems and quality management solutions environment.
• Conducted Trackwise (change management module) testing using HPQC.
• Communicated risk and compliance issues regarding PKS validation.
• Conducted meetings with the team members to point out the deficiencies in requirements and suggested the ways to cover it.
• Authored and reviewed the following types of documents: User/ Functional Requirements, Technical Design Specifications, Validation protocols (IQ, OQ, PQ) and validation final reports.
• Responsible for coordinating with team members in locating, tracking, organizing and verifying validation documentation for cGMP compliance and regulatory requirements.
• Reviewed the User Requirements and prepared the detailed Test Plans and Test Criteria.
• Developed, reviewed and executed Test Cases.
• Involved in deficiency investigations, reviewing and preparing SOPs and quality system development.
• Designed and wrote training manual templates and was involved in project planning.
• Generated and submitted the weekly status reports.

Confidential

Technical Writer

Responsibilities:

• Designed, developed, tested and implemented EMBRs (Electronic Master Batch Records), in accordance with company’s Quality Systems, FDA compliance, and other regulatory standards.
• Lead the analysis of the Batch Record requirements and developed EMBRs, design documents and test scripts in accordance with SOPs (Standard Operating Procedures) and SME (Subject Matter Experts) input.
• Developed the design process including gap analysis, design document creation, and prototype development to support design reviews.
• Created and maintained EMBRs associated test scripts and submitted change controls while meeting and reporting on development deadlines.
• Acted as liaison between Manufacturing, QA and QC in responding to commitments and change control items concerning SOPs and EMBRs.
• Ensured the final EMBR meets the department business requirements and is reviewed by Shop Floor Personnel, Production Management, Technology, Safety and QA.
• Trained end users in batch record execution.
• Developed and revised SOPs, using document management tool to control review and approval cycles.