At Jabil Healthcare, my mission as a Computer System Validation Lead revolves around ensuring systems comply with critical FDA regulations, cementing the foundation for high-quality patient care. My role requires meticulous oversight of GxP systems, where I employ my expertise in manufacturing process improvement and virtual collaboration to maintain compliance with 21 CFR Part 210, 211, and 820.My efforts are geared towards safeguarding data integrity, which is pivotal for inspection processes, manufacturing efficiency, 21 CFR Part 11 requirements and robust quality management systems. The organization has benefited from my contribution and driving global remediations, which are vital for lifting FDA Warning Letters. In this capacity, I leverage my skills and proficiency in Quality Assurance to champion regulatory compliance and uphold the highest standards of patient safety.

Ensure the CSV program is rolled out to the facility to meet our corporate and regulatory requirements. Work collaboratively with my collegues to produce CSV documents and ensure they have been developed in compliance with our policies, includes, but not limited to compliance analysis, compliance plan, F/URS, risk assessments, residual risk analysis, supplier qualification, test scripts for performance qualification, compliance final report, traceability matrix.Report metrics on % compliance to program and have remediation efforts in progress to achieve 100% compliance goal. Most importantly act on behalf of our customers (the patients and consumers) to ensure our systems produce the highest quality product and minimize any risk to consumer health (poor quality product, mix-ups, etc.)

Worked as Validation Specialist from August 2012 to January 2014, was promoted to a newly created position to manage a team of GxP Specialists which support all GxP Software Implementation functions, including all computer system validation activities.Appointed head of computer validation for Luitpold and our sister company Pharmaforce.Prepared GxP Systems Inventory list at Pharmaforce which helped PFI pass PAI.Chose a team comprised of individuals with specific areas of interest: Quality Assurance, Quality Control and Manufacturing Operations.Manage various software implementations and introducing GAMP5 approach to computer system validation. Elected to chair QIP subteam for electronic records. Elected to represent QA team at Quality Council.Implemented vendor auditing program in order to justify relying on vendor documentation of application testing from vendor. Managed the risk assessment to ensure we chose a representative example to prove system compliance to Part 211 and Part 11 for GMP regulations.All new system implementations (ISOtrain (iKAT), MODA-EM, Waters Empower) have had combinations of onsite and postal audits performed to qualify the supplier for software systems implementations.Implemented a Zero Sampling Plan to support data migration initiatives for new systems to be able to run reports on historical/legacy information.

Validation Engineering Manager Responsibilities include but not limited to: Master Validation Plan implemented along with Validation Department SOPs. Created Validation RoadMap. Participated in all third party vendor audits.Generated the FRS and SRS for the pilot implementation and as processes are developed generate the test scripts for the IQ/OQ/PQ execution including all Part 11 requirements being met.IQ/OQ/PQ generated, executed and Summary Report approved for Purified Water System and Blend Skid Compounding Equipment.Process Validation has been initiated for FDA Regulated OTC products with Cleaning Validation Protocols being drafted for approval as the QC Methods are validated.Steering an eDMS project for control of site SOPs, Forms, Formula Batch Sheets.

Negotiated with EtQ, Inc. to bring in Reliance Software version 7.0 to establish quality systems for the manufacturing facilities in order to comply with newly enforced Code of Federal Regulations Title 21 Part 111.Configured Complaint Handling module with Decision Tree logic to ensure all investigations were performed depending on keyword indicators. This module is a response to a 483 observation.Performed a Gap Analysis of all complaint notifications received versus answered since regulations came into effect in order to ensure the complaint handling system is in compliance and all data was reworked into an importable spreadsheet for legacy data migration.Responsible for OQ/PQ of Reliance QMS, to ensure the system has been configured to meet Part 11 standards and that all workflows and configuration forms have been documented and are working as per FRS/URS. Generated Traceability matrix to map each test case scenario along with acceptance criteria back to the FRS/URS or GMP regulation.Responsible for managing all in-process manufacturing deviations from event notification to disposition of event and subsequent bulk manufactured product as decisions are made by Material Review Board.Manage all incoming raw material inspections and provide documentation of nonconforming materials for Material Review Board.Perform facility walkthroughs and internal audits and report findings to executive management for corrective action determination.Rebuilt Safety & Security SOPs in preparation for OSHA audit where previously received findings, specifically for nonconformance of Lock Out/Tag Out procedures. Trained all company personnel on the new procedures and implemented the new Lock Out / Tag Out program.Coordinated efforts to bring in a respiratory protection program in order to determine the level of required protection by department exposure to nuisance dust and particles.

Client Account Management Responsibilities include but not limited to:Run initial onsite requirements gathering session with client to design the process for which the clients required outputs are agreed upon to successfully implement the modules in scope for the implementation process. These requirements are analyzed for complexity and traced back to the Business Requirements in order to map out the configuration specifications for the project.Produce Form Specifications, Process Flow Maps, Data Flow Maps, Parent-Child Document Relationship Diagrams, User Interface Specifications (Views, Dashboard, Online Reports), Permission Management Documentation.Show customer how to build tables and import ERP (Enterprise Resource Planning) data to integrate Quality System with ERP Data based on customer DBA table definitions.Create and maintain project timelines, design specifications, business requirements, user requirements, scope matrix, and consult customer on successful implementation of software.Advanced configuration includes modifying the data sources (SQL) to query database and Python coding for application automation. Modify configuration form to enhance formatting using HTML code.Perform follow-up web training with the customer to answer application questions and provide guidance to ensure the company is meeting their compliance requirements.Execute Validation Scripts using Native and Composite Commands with the software to test the configuration settings, which are identified in the SDLC or System Specification Documentation.

Facility/Equipment Qualification Responsibilities include but not limited to:Executing projects based on Validation Master Plan.Executing generated protocols to increase production output and decrease downtime Analyze vendor and engineering drawings for installation qualification of new production equipment.Manage Production Equipment/System assessment program that identifies protocol deficiencies.

Quality Management System Administration Responsibilities include but not limited to:Analyzing process flows for systems (Deviation, CAPA, Amendment Investigation).Revise user information, selection lists, group category permissions and activity state machinePrepare flowcharts using Visio2000 to illustrate system requirements as well as process flows for individual project configurations.Regularly presented Trackwise configurations of projects and report functionality to Quality Improvement leadership team. (Crystal reports)Managed site validation (IQ/OQ/PQ) for Trackwise, which included creation/execution of user scripts, site SOP creation/implementation across all projects including contingency plans.Identify and train personnel on SOPs, Corporate Documentation, approved workflows as well as Adobe Ancillary Visual Documentation.Responsible for making required contributions for the creation/revision of functional and user requirement specification documentation.Revision of cGMP SOPs (Material Control/Change Control/Complaint Investigation/Internal Auditing) to align SOPs with future configuration compatibility.

Project/process administration Responsibilities include but not limited to:EDMS Business Liaison for all ANDA post approval submission strategiesSite lead responsible for eCTD submission team alignment.Site lead responsible for Regulatory Label Development and Process Deployment for eCTD submission to FDA.Providing workflow structures for leadership to identify key elements of the process.Administer label-printing system, which provides users with a validated environment to generate GxP labels.Create/maintain folder structure of controlled effective cGMP documentation for distribution.Change control logging for tracking/trending of metrics. Utilize Excel in a GMP environment.