SUMMARY

• Over Seven years of experience as Validation Analyst, Quality Assurance Analyst and Technical Writer in the Pharmaceutical and Biotech industry.
• In depth knowledge of FDA regulations 21 CFR Part 11, 56, 58, 210, 211, 820 and participation in implementation of 21 CFR Part 11 rules like Electronic Records, Electronic Signatures and Audit Trails.
• Thorough experience with the Software Development Life Cycle (SDLC) approach and documenting / reviewing validation deliverables and Technical Writing.
• Developed strategies and plans to install different types of systems that fall under GxPs (cGMP, GCP and GLP) and GAMP.
• Experience in review and development of Project plan, Validation Plan, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS)
• Requirement Traceability Matrix (RTM), Validation Protocols (Installation / Operation / Performance Qualification) and Summary reports in compliance with GxPs.
• Worked with a SOP committee in writing / reviewing / revising software and hardware Standard Operating Procedures (SOPs) and User Manuals to ensure that they meet FDA requirements.
• Experience of performing GAP analysis, preparing Remediation Plans, Prospective and Retrospective Validation.
• Excellent experience in performing Risk Assessments.
• Good experience in reviewing and performing Corrective and Preventive Actions (CAPA).
• Good experience in writing Deviation report, Discrepancy report and User Acceptance Testing (UAT).
• Extensive experience in preparing Validation Summary Report (VSR) and Test Summary Report (TSR).
• Good knowledge on the laboratory instruments such as HPLC, GC, MS, LC, TLC, GC - MS, UV-VIS Spectrochemical Analyzer, Dissolution, Disintegration and Differential Scanning Colorimeter.
• Excellent knowledge and experience in Good Documentation and Good Testing Practices.
• Strong experience in Laboratory Information Management System (LIMS), Adverse Events Reporting System (AERS).
• Good experience in performing manual testing like Integration Testing, Black Box Testing, Functional Testing, Regression Testing, Backend Testing.
• Good knowledge on automated testing tools like Mercury Quality Center, QTP.
• Expert in maintenance and update of Test Scripts.
• Good experience in developing Test requirements, Test Strategies, Test Plans, Test Procedures, Test Cases and testing standards.
• Good experience of Documentum.
• Excellent leadership skills with the ability to motivate teams to achieve company goals.
• Proven ability to prioritize tasks, meet project deadlines as scheduled and within budget.
• Proficient computer skills with the use of Microsoft Office and MS Visio.
• Interfaced well with diverse groups of people including senior managers, vendors, customers, quality control, quality assurance and team members.
• Enthusiastic, self-motivated, resourceful, highly organized, ability to multi-task, work under pressure and proficient in onsite/offshore coordination.
• Excellent interpersonal, organizational, project management, oral and written communication skills.

TECHNICAL SKILLS

Packages: Ms Office Suite (Word, Access, Excel, Power Point) MS Visio, MS Outlook

Operating Systems: Microsoft Windows, UNIX, MS-DOS

Testing Tools: QTP, Mercury Quality Center

Standards: 21 CFR Part 11, 820, GMP, GLP, GCP

Programming Languages: C, SQL

Web Technologies: HTML

Databases: Oracle, SQL Server

PROFESSIONAL EXPERIENCE

Confidential, CT

QA (Quality Assurance) Representative

Responsibilities:

• Provided guidance on product Quality and Compliance.
• Communicated Quality Assurance policies and guidelines to project team members as appropriate.
• Approved project deliverables as appropriate.
• Resolved queries on Quality Assurance processes.
• Provided overall mentoring guidance to the team on proper use of ELC and SDLC procedures.
• Verified deliverables from a Quality Assurance (compliance) perspective and signed applicable SDLC and ELC documents.
• Provided overall Quality Management guidance to project team.
• Reviewed and approved all appropriate documentation as outlined in the Deliverables Signature Matrix for the project.
• Reviewed documents for: compliance to quality and regulatory requirements, Good Documentation Practices and Good Testing Practices, particularly provided guidance on the test approach.
• Provided guidance and participated in Regulatory (GLP, GCP, GDP and GMP) assessments and maintained Electronic Records and Electronic Signatures according to 21 CFR Part 11, 210 and 211.
• Assisted Confidential internal auditors at the time of audit. Change Control Review.
• Confirmed that project artifacts and application compliance risk and information protection meet Confidential quality standards.
• Initiated and/or reviewed and confirmed Compliance Risk Profiles (CRP).
• Supported the Tailoring of the project through identifying deliverables and the appropriate signatories as per the agreed methodology.
• Supported in the elicitation and documentation of the Business Requirements, User Requirements and initiation of the Functional requirements.
• Facilitated the Generation and provisioned the IT- compliance requirements (My requirements from the CRS (Common Requirements Set).
• Coordinated with vendor assessments as necessary.
• Reviewed and approved the Tailoring Form, Project Plan, Requirements and Design Specifications, Test Plan, Test Scripts and Test Summary Report documents.
• Reviewed Requirements, Design, Build, Test and Deploy Stage Gate Checklists and Requirements Traceability Matrix.
• Documented the deviations and corrective actions in CMRS (Compliance Management Reporting System) Trackwise tool.
• Provided application team support in answering the Disaster Recovery (DR) related questions on the CRP (RTO (Recovery Time Objective) / DR Tier).
• Ensured the controlled environments are under Change Control (production environments and immediate pre-production if available).
• Authored the Application Declaration of Validation Memo and the Compliance Report.

Confidential, NJ

Validation Analyst / Technical Writer

Responsibilities:

• Worked collaborately with research and development and manufacturing personnel in the preparation and review of documents.
• Involved in calibration of HPLC and GC and participated in checking its accuracy, detection limit, noise level, precision, repeatability, reproducibility and robustness.
• Reviewed and developed User and Functional Requirements.
• Wrote and reviewed OQ and PQ protocols.
• Rewrote various sources of information into a uniform style and language for regulatory compliance.
• Maintained Requirement Traceability Matrix to track requirements.
• Conferred with representatives, vendors, plant executives to establish technical specifications.
• Gathered information from Subject Matter Experts and developed unified, consistent documents.
• Wrote and reviewed Standard Operating Procedures (SOPs) and User Manuals to ensure they meet FDA requirements.
• Reviewed and modified existing Standard Operating Systems (SOPs).
• Prepared Validation Summary Report (VSR) and archived all documents to make sure they were in compliance with 21 CFR Part 11 regulations.
• Reviewed published material and recommended changes or revisions in the scope, format, content and methods.
• Maintained records and files of work and revisions.
• Good knowledge on validation of Chromatography Data Systems and responsible for development of system, risk management, operation, system retirement and data migration plan.
• Prepared the test Cases by going through the Design, Functional Requirements and User requirements.
• Performed extensive Manual Testing such as Black Box Testing of the application.
• Documented Test Cases for Integration, Functional testing and User Acceptance testing.
• Responsible for weekly status reports, updated the progress of Manual Testing.
• Responsible for writing Test plans, Test scripts. Verified test results and wrote Test Summary Reports.

Confidential, Philadelphia

Validation Engineer

Responsibilities:

• Wrote documentation for all aspects of the computer systems validation lifecycle, in accordance with FDA regulations, particularly 21 CFR Part 11.
• Responsible for performing Risk Assessment.
• Responsible for working with all phases of the SDLC in the Validation process of LIMS.
• Developed and updated the Requirement Traceability Matrix (RTM) to track requirements during the QA Testing Phase.
• Developed test plans, test strategies, test scripts for validation testing along with the Test Summary Report (TSR).
• Logged errors on the error tracking system and re-executed the test cases upon resolution.
• Responsible for validating the reports generated by the LIMS application are in compliance with 21 CFR part 11 requirements.
• Attended weekly status meetings with Team lead, Project Manager and Subject Matter Experts to update work progress.
• Good knowledge on laboratory system such as BioBook.
• Extensively involved in Testing phase, which include various testing activities like Regression Testing, Black Box Testing.
• Defined various scenarios for testing the application to meet the critical requirements.
• Interacted with the Developers and Subject Matter Experts (SME) to better understand the workflow and functionalities on different modules.
• Responsible for documentation of all aspects of the Computer System Validation Life Cycle in accordance with 21 CFR Part 11, GLP, GCP and GMP.
• Responsible for writing Work Instructions for Change control.
• Interacted with developers to resolve technical issues and investigated the bugs in the application using Test Director.

Confidential, CA

Technical Writer / Validation Engineer

Responsibilities:

• Gathered User Requirements for all the software components from the System Owners document.
• Developed FRS (Functional Requirements Specification) and DS (Design Specification) from the URS (User Requirements Specification).
• Responsible for reviewing and documenting Validation Plan, OQ/PQ protocols and Validation Summary Report.
• Actively involved with the application developers in developing the high level System Design Specification (SDS) documents.
• Used Ms Visio for pictorial representation of the Design Specifications and workflow of the process.
• Involved in documenting Vendor Assessment Report from a list of AERS suppliers.
• Developed Requirement Traceability Matrix (RTM) to track requirements during the QA Testing Phase.
• Checked the modules of the application and used SQL queries to extract the data from database.
• Involved with the development team to verify bug fixing and update bug report status using Mercury Quality Center.
• Responsible for writing change control SOP’s to comply with 21 CFR Part 11 requirements.
• Developed test plans, test strategies for validation testing.
• Responsible for developing test scripts for audit trail, time stamp and electronic signature for the work flow of documents.
• Prepared training documentation for the various SOP training.
• Involved in writing audit plans for the quality department.
• Expertise in performing assessments on documents and systems.
• Hands on experience in review of documents with respect to QA aspects.
• Successfully coordinated meetings with the users, management and vendors.

Confidential

SQA Validation Engineer

Responsibilities:

• Reviewed User Requirements Specification, Functional Requirements Specification and developed Test Cases.
• Excellent knowledge on all phases of SDLC (Software development life cycle).
• Prepared and reviewed Test Cases to meet the business requirements.
• Executed Test Cases, reported bugs, regressed bugs and tracked the system test status.
• Involved in Black Box, Functional, Integration, Regression, and System Testing.
• Good working knowledge on automated testing tools like Mercury Quality Center.
• Prepared, reviewed, and executed all documents related to computer system validation activities which include Validation Master Plan, Test Protocols and Use cases using UML (Unified Modeling Language).
• Maintained Requirement Traceability Matrix.
• Responsible for reviewing and documenting Validation Protocols including IQ (Installation qualification), OQ (Operational qualification) and PQ (Performance qualification) and Validation Summary Reports.
• Prepared Standard Operating Procedures (SOP) in compliance with 21 CFR Part 11, Deviation Reports (Deviation reports & Logs), Change management (Change Controls).
• Responsible for writing Test Plans, Test Scripts and Test Summary Reports.
• Good knowledge on HPQC.
• Good experience on documenting software and business requirements.
• Worked with Software Quality Control (SQC) on changes to code and met program and compliance criteria. Additionally worked with this group to support validation corrective action for the application.
• Implemented policies needed for an effective validation program to ensure compliance with FDA regulations and guidance documents including GxPs, 21 CFR Part 11 and industry accepted pharmaceutical practices.

Confidential

Quality Assurance Analyst

Responsibilities:

• Maintained the quality system continuous improvement program through implementation and maintenance of quality standards and regulatory requirements.
• Reviewed production documentation and assisted with batch release procedures.
• Good knowledge on FDA Regulations 21 CFR Part 11, 56, 58, 210, 211, and 820.
• Performed QA activities which include review of change controls, work orders and validation in compliance with GxPs.
• Ensured that the regulatory and quality requirements were met during routine operations.
• Created, revised and reviewed SOPs for department and other areas as applicable.
• Performed batch release of drugs and device products.
• Participated in audits together with follow up.
• Responded to quality related queries from other department.
• Supported the timely release of products to the market.
• Reviewed and reported activities related to the Quality Management Systems (QMS).
• Assembled and maintained department quality reports for management review to include track and trend data analysis.