Eric Cook Email & Phone Number

Remote

St Petersburg, Florida, US

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.

Raynham, MA, US

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.

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.

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.

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.

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.

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.

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.

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.

Bachelor'S Degree, Psychology

Education record