Omar Suarez Email and Phone Number

• Perform process/cleaning validations and post monitoring in a GMP facility. Participate in process/cleaning development activities including parameter selection, determining order of collection swab samples, sampling, and data analysis.• Managing process/cleaning validation, interacting with all involved department, Manufacturing, Quality Control, and Quality Assurance in the execution of validation protocols. Developing and communicating projects timelines and status.• Author of process/cleaning validation protocols and reports. Review of process/cleaning validation protocols/reports and assure that protocols/reports are approved though proper channels. Assuring those acceptance criterions related to validation are met.• Contributing and supporting OpEx initiatives (Cleaning Campaign Length, DEHT, & CEHT) to improve operational performance of TEVA Forida Site. Enhancing Cleaning Campaign Lengths of commercial products to increase productivity and reduce risk of back orders.• Assisting with on-site transfer projects and product scale-up regarding cleaning validation activities.• Initiate, review, and approve thought Change Control Departmental SOPs in order to update cleaning status of manufacturing equipment and to optimize Pharmaceutical Technology process.• Independently perform investigation (TWRs) as required upon chemical failures of the API’s and Cleaning Agents, to determinate the root cause of not meeting the protocol acceptance criteria. Determinate solutions and recommendations for changes and/or improvements. Ensuring the effectiveness check is completed for all required preventive and corrective actions.• Performing training for Manufacturing/ R&D Operators / Pharm Tech Technicians on necessary protocols, methods (swab and visual inspections) and related SOPs.