Computer System Validation Compliance (CSV).Maintenance of the Validate State for Systems Category 4 and 5 (GAMP 5) such as Manufacturing Execution System MES following the guidelines dictated by FDA

• Key Sponsor of an application category 5 (GAMP 5) to manage, monitoring and control of the new version releases.• Use PM Tools to Coordinate and manage all the activities related to new releases for al de key users in multiple worldwide sites. • Project Portfolio Management, project schedule, resource, communications, and scope management.• Manage user requirements from multiple stakeholders and sites for the next releases. • Developing a communication plan to manage changes related to new system releases.• Development of a training plan for key users, guaranteeing the updating of processes related to new releases

• Lead investigations with the team to root cause and the development and implementation of corrective action plans.• Supported CAPA Remediation process by reviewing retrospective supplier CAPAs for completeness to address CAPA plans, root causes, implement corrective actions, and effectiveness checks.• Project Portfolio Management, project schedule, resource, communications, scope management.• Improvement of test case template for design of Operating Parameters experiments aimed to determine the accepted operating ranges and related worksheets, to implement individual samples inspection raw data collection and statistical analysis/evaluation for packaging and production equipment.• Development of validation life cycle documents (VP, URS, DQ, IQ-OQ-PQ, TM, VR), execution of IQ-OQ protocols, and support to PQ executed by end user for packaging, laboratory (LabX software and Titrator, pH meters, UV-Vis spec, balances, Flame photometer, Osmometer, Polarimeter) , and production equipment• Revision and development of risk analysis FMEAs integrating missing risks scenarios.• Assessment of site qualification/validation package.• Integration of validation study with Installation, Installation Verification, and Verification tests.• Re-Validation of the computer system performing a GAMP5 V cycle including control system validation and 21 CFR Part 11/Data Integrity compliance verification, focusing on clear definition of regulatory requirements, and regulated electronic records• Working with project teams to select methods and techniques for obtaining desirable solutions for each project and working with QA to ensure compliance with the regulation. • Ensure that all the documentation complies with FDA and cGMP regulations and provide technical support to the validation group as needed.• Developing final reports summarizing qualifications. Tracking and managing the change control activities for multiple concurrent projects..

• Project Portfolio Management, Medical device packaging savings projects, Process Validation Projects.• Manage project outcomes by identifying, minimizing, and mitigating risks. Definition, prioritization and manage tasks within a project. Crisp decision-making and recommendations following appropriate consultation between stakeholders.• Supplier management to reduce production costs.• Statistical analysis of time and loss of products to improve production and packaging processes.• Change Control Management

• Project management / coordination activities through development/review of project plans / Gantt, status update reports/presentation, project issues tracker and technical problem solving, resources workload plans, meeting agenda/minutes, budget monitoring.• Management of suppliers for the acquisition of production and packaging equipment, engineering activities, civil works, sanitary finishes.• SAT for production and packaging equipment• Management of validation and qualification activities• Change Control Management

• Management and Development of Automation Projects• Preparation of SDLC documentation (System Development Life Cycle) for computer systems for production equipment, laboratory equipment and critical systems in pharmaceutical site, compliance with Data Integrity requirements (GxP, 21CFR11)• Development and execution of validation protocols for CSV (Computer System Validation) systems for production equipment, laboratory equipment and critical systems under quality compliance (Deviation, CAPAs)

• Coordination & Implementation of a new framework for FDA approval, compliance with GAMP 5, 21 CFR 11 and NOM (Mexico & Puerto Rico)• Support to Audits for Software Validation area• ERP system validation - Microsoft Dynamics AX, Master Control in Pharmaceutical sites in Mexico and Puerto Rico• Project Management Validation of computer systems, production equipment, laboratory and critical systems in Mexico and Puerto Rico (DQ, IQ, OQ & PQ)• Development and execution of protocols for the qualification / validation of computer systems (GxP), production equipment, laboratory equipment and critical systems.

• Qualification & Validation of Equipment, and Processes in pharmaceutical site• support in orientation and advice to the patient

• Qualification & Validation of Equipment, and Processes in pharmaceutical site• Development and execution of DQ, IQ, OQ and PQ protocols• Support in the elaboration and execution of cleaning validation protocols and critical systems