- Qualified Professional with experience in Computer System Validation (CSV) with expertise in CSV deliverables in FDA regulated biotechnology, medical device, and pharmaceutical industries. Working experience in FDA regulated environment with expertise in implementing 21 CFR part 11, Part 210 / 211 and 820. A team player with excellent communication skills, interpersonal skills, and an ability to meet challenging deadlines. Skilled in technical writing, reviewing test scripts and execution of test cases.
- Experienced in preparation and review of validation protocols and reports for IQ/OQ/PQ, validation plan (VP), Validation Summary Report (VSR), and writing and updating SOPs.
- Hands on experience in drafting, reviewing, and executing test scripts (IQ, OQ, PQ).
- In - depth knowledge of FDA regulations 21 CFR Part 11, 210 & 211, 820 and EU Annex 11.
- Strong knowledge of GAMP 5, GLP, GCP, GMP and GDP guidelines.
- Experienced in resolving protocol deviation using root cause analysis, FMEA, 5 Whys, contributing to risk assessment, and change control.
- Experienced in performing, Impact Analysis, and System Compliance Assessments .
- Participated in performing gap analysis, risk assessment and project validation plan.
- Good Understanding of periodic review process and periodical evaluation report.
- Served as a liaison between vendors and stakeholders.
Quality Systems & Applications: ISO, SRS, QMS, Documentum, Veeva Vault, eDocs, TrackWise, Compliance Wire, EDMS, and LIMS
Industry Regulations: 21 CFR Part (11, 210, 211, 820), GxP (GLP, GCP, GMP), and Annex 11
Others: MS Excel, MS Office, MS Power Point, MS Share Point, Visio, Quickbooks, Taleo, Intelligent Bill Payment Platform, and Redmine
Confidential, San Francisco, CA
- Responsible for developing validation deliverables for Clinical Systems in collaboration with the business to support system validation activities.
- Reviewed and authored validation deliverable's (URS, FRS, CS, IQ, OQ, PQ, and VSR) as per the client’s EDMS workflow following the validation plan.
- Executed IQ, OQ, and PQ following Good Documentation Practices.
- Generated and reviewed CSV deliverables in compliance with 21 CFR Part 11 and GxP company SOPs.
- Reviewed pre-executed package provided by vendor to identify gaps and risk associated with the project and authored test protocol to mitigate all the gaps and risks.
- Followed departmental and company-wide SOPs, policies and procedures for software quality assurance directly contributing to validation deliverables.
- Supported change control activities, deviations, and SOP's for clinical systems. Used TrackWise to manage change control.
- Reviewed business and quality test cases and analyzed the results by using HP ALM.
- Worked closely with clinical operations, regulatory, IT and Clinical Research Quality to develop, coordinate and execute validation deliverables and strategies.
Confidential, Cambridge, MA
- Followed Computer Systems Validation CSV Master Plan to author, review and approve CSV deliverables for systems as per project requirements and company SOPs.
- Wrote and executed Installation qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols to check installation and successful operation.
- Drafted, reviewed, and executed IQ, OQ, and PQ documents for two modules of Veeva Vault: Libraries and Reports.
- Participated in writing and reviewing IQ, OQ, and PQ protocols for Confidential ’s learning management system.
- Authored and reviewed CSV deliverables such as Validation Plan, URS, RTM, IQ, OQ, PQ, Periodic Review Report and Validation Summary Report for laboratory information management system (LIMS), and routed for review and approval using tools like HP ALM and SharePoint.
- Participated in a cross functional team to conduct validation deviation and found the root cause of failure using tools such as cause and effect and 5 Why’s.
- Created and maintained the Requirement Traceability Matrix (RTM) between URS and Functional Requirements Specifications (FRS), design specification, IQ, OQ, and PQ test documents.
- Executed test cases based on the test plan and in accordance with Good Documentation Practices (GDP).
- Created Validation Summary Report (VSR) to summarize overall validation activities.
- Organized, maintained and archived validation documentation.
- Collaborated with IT, Business, Regulatory Affairs, and Quality to develop, coordinate and execute validation test strategies.
Confidential, Boston, MA
- Prepared an annual budget, projected profit, and loss projections, provided operations and personnel budget plan to executive board for review and approval.
- Managed day-to-day operations, supervised direct and indirect reports in different areas including manufacturing, production, supply chain, procurement, distribution, inventory, and compliance.
- Supported the people side of process change through proven change management methodologies while working closely with the project management team.
- Developed and maintained task assignment in JIRA to the team to keep track on tasks completed.
- Planed and implemented office systems, layouts, and equipment procurement.
- Monitored and implanted OSHA training and other health, safety & environment programs
- Responsible for IT efficiencies, maintenance and resolved technical issues that require in-depth analysis, such as application, hardware, and software problems.
- Managed and monitored desktops, servers, and remote access.