Quality reviewer for SDLC documentation.

Provide quality support for deployment of JDE 9.1. Provide Quality insight and guidance on all aspects of documentation, testing, quality review etc. Manage the investigation and deviation process to ensure focus on root cause determination and timely closure. •Write, review, revise, and approve Quality related documentation (batch records, SOPs, specifications, protocols, deviations, investigations, CAPA, etc.)•Manage the investigation and deviation process to ensure focus on root cause determination and timely closure.

• Quality Auditor for 88 ongoing projects involved in the Software Development Life cycle. • Guide Oncology IT organization in FDA and government compliance on projects during various stages of SDLC delivery for each project.• Review and audit deliverables per software phase for quality. Provide direction for non-compliance and correction.• Audit documentation for projects/applications, both GxP and non-GxP, for compliance, Security, Privacy and Financial regulations.• Ensure adherence and verify compliance to Novartis Quality, Project Management & System Management Work Instructions and Novartis SOPs.• Lead weekly Tollgate (life cycle) meetings to pass or reject moving to the next stage of life cycle based on weekly documentation cycle review.• Provide guidance in weekly Tollgate meetings on compliance, system delivery and testing• Advise project teams on compliance to FDA and Novartis Quality Procedures and SOPs• Ensure quality across all projects, globally and internationally.• Write, review and provide guidance on Oncology IT SOPs.

Twenty-five+ years Computer Systems Validation (CSV), Testing, Quality Assurance, IT Compliance, FDA & 21 CFR Part 11 software testing, IT Testing, Quality Management. Quality Reviewer and Writer of Software Development Life Cycle (SDLC) documentation including Validation Plans, URS/FRS System and UAT Plans, Test Scripts, Traceability Matrices and Validation Summary Reports. Expert in writing, reviewing and preparing CSV documentation, including SOPs.Expert in writing, review (pre and post-approval) for all CSV deliverables, expertise in Quality Auditing for 21 Part 11, including SOP’s.

Ensure IT and manufacturing projects globally for Merck were compliant with Merck Consumer Care (MCC) SDLC SOP and validation procedures via monitoring projects, audits, and periodic reviews.Sr. IT Compliance Lead writing Quality Plans (i.e., Validation Plans) and User Acceptance SDLC deliverables, including Quality (Validation) Assurance Summary Report and other deliverables as needed by the business; • Advised project teams on compliance to FDA and Merck’s Quality Procedures• Wrote Standard Operating Procedures for MCC IT Compliance Department.• Developed standard Quality/validation templates for SDLC validation deliverables• Developed and reviewed Validation deliverables for multiple global projects.• Provided technical assessment & validation approval for engineering & process changes.• Communicated and coordinated validation activities for IT Compliance.• Actively participated in technical decisions affecting product modules/sub-systems • Provided quality, test and regulatory guidance on multiple projects.06/2011 to 01/2012 Sr. Validation Specialist, IT Quality Assurance -Validation & Compliance Lead on upgrade to CRLIMS system and MIDAS (Doc. Mgmt. System). - Developed and reviewed Validation deliverables for multiple projects.- Worked with clients to document and create SDLC deliverables; Part 11 and GMP Assessments- Reviewed User and System Requirements Specifications as well as Design Specifications- Created Standard Operating Procedure for validation procedures for newly created department.- Provided Training in testing and Good Documentation for team and testers.- Provided technical assessment and validation approval for engineering and process changes.- Communicated and coordinated validation activities for IT QA.- Managed testers who developed & executed test scripts.Reviewed executed test scripts for compliance. - Actively participated in technical decisions affecting product modules and/or sub-systems.

- Performed Gap Analysis to determine validated state of BCI’s Document Management System (EDMS) and electronic signature application.- Audited/reviewed validation documentation for Quality Assurance and 21 CFR 11 compliance.- Managed remediation and re-validation activities. Provided validation templates for all Validation deliverables for remediation and revalidation effort for EDMS.- Worked with clients to document and create Validation Plan, functional, technical and design specifications, CSV, Part 11, and GMP Assessments- Created/Updated User and System Requirements Specifications as needed for remediation. - Provided and completed Risk Assessment and Part 11 Assessments, templates and training.- Provided Training in testing and Good Documentation Practices (GDP) for EDMS team and testers.- Provided technical assessment and validation approval for engineering and process changes.- Provided guidance on new regulated policies that affect computer systems validation.- Implemented new validation procedures and testing strategy to re-validate, document, qualify, and test in respect to good software engineering practice and specific regulatory requirements specifically 21 CFR Part 11. - Communicated and coordinated validation activities IT QA.- Perform quality activities such as audits, procedure development, product release, documentation review and define changes to controlled documents. -Provide guidance on Standard Operating Procedures (SOPs) for Validation, SDLC and Quality Assurance processes. - Implement innovative, effective and efficient test design solutions in a timely manner.- Assists, in the establishment of functional specifications; work objectives; actively participates in technical decisions affecting product modules and/or sub-systems.

- Validation Manager - Manage validation resources for Valiation Group implementing various clinical trial and imaging applications. - Manage and oversee concurrent computer systems validation activities for RadPharm’s 23 clinical trial applications. - Manage a team of validation specialists and engineers that performed validation activities. - Hired both permanent and contract personnel for validation projects. Included resource allocation, performance appraisals, performance improvement plans, etc. - Responsible for managing the state of compliance of all computer systems, ensuring that internal systems and methodologies meet or exceed FDA requirements as per cGCP/21 CFR 11 compliance. - Rreviewed and executed all validation life cycle documentation as appropriate: Validation Plans, test plans, technical reports, and procedures as well as OQ Protocols (System Test Plans), UAT and Validation Summary documentation. - Assisted in sponsor audits for computer systems validation.- Interpreted and provided company with guidance on regulatory and compliance issues including Part 11 and validation.- Reviewed all validation documentationfor Quality Assurance and 21 CFR 11compliance. - Responded to QA review, advised/eveloped compliance practices/ procedures and independently assessed compliance practices and provided recommendation for corrective action (CAPAs).- Wrote company standard operating procedures (SOPs) that govern validation, SDLC and Quality Assurance activities.

Senior Validation Specialist for Informatics Management QA Sale & Marketing organization. Quality Assurance (QA) assessed and reviewed all QA/validation documentation for 21 CFR 11 compliance and validation.Work with clients, QA and validation staff to review/update and approve all documentation.Create validation documentation for compliance to FDA regulations including Validation Plans, Test Plans, UAT scripts, Validation Summary Reports.Hands-on Validation Specialist/Test Lead overseeing System and User Acceptance Testing. Created test plan and test scripts as per functional requirements and design documents.Quality assurance review of deliverables for 21 CFR 11 and FDA regulatory compliance.Prepared documentation that follows FDA guidelines and regulations such as FDA Title 21 CFR Parts 11 and 820, Title 61 FR 52602 and CDRH General Principles of Software Validation as well as in-house SOP’s.Interpret and provide clients with guidance on regulatory and compliance issues including Part 11 and validation.Senior Validation Specialist for QA Sale & Marketing Siebel application. Quality Assurance (QA) assessed and reviewed all QA/validation documentation for 21 CFR 11 compliance and validation.