QC Laboratory Operations Manager

• Jul 2023 - Present

-Supervise and improve operations in the QC Lab of an EDA and PPTA certified organization aiming for FDA and EMA certifications. -Train and supervise lab specialists for adequate performance of lab techniques. - Work closely with team members to provide effective solutions to support business and quality objectives. - Ensure the lab establishes and maintains a calibration program for testing equipment that affect quality results. - Facilitate effective communication across… Show more -Supervise and improve operations in the QC Lab of an EDA and PPTA certified organization aiming for FDA and EMA certifications. -Train and supervise lab specialists for adequate performance of lab techniques. - Work closely with team members to provide effective solutions to support business and quality objectives. - Ensure the lab establishes and maintains a calibration program for testing equipment that affect quality results. - Facilitate effective communication across internal departments by trending and reporting data. - Ensure adherence to regulatory requirements, budgets, and schedules. - Establish and improve procedures and processes by addressing issues and risks. - Utilize proven employee management solutions to improve productivity and efficiency. - Ensure that all materials are ordered, that samples are handled correctly, and that lab time is allocated adequately. - Establish and maintain health and safety protocols. - Evaluate possible deviation detected during the process as well as to propose measures to correct and prevent redundant or new deviations. - Establish Validation plan for all the equipment and testing methods. - Review and approval of validation reports related to testing methods in use in Plasma testing Laboratory. - Establish a Proficiency Test program for the testing performed in the QC Laboratory. - Maintain updated the Technical Information of the Plasma Testing Laboratory and optimize the resources and testing process. - Maintain updated the Technical Information of the Plasma Testing Laboratory. - Participate and support Regulatory inspections and audits. - Evaluate Regulatory Inspections and audit reports and review of corrective and preventive actions derived from the observations found. Show less -Supervise and improve operations in the QC Lab of an EDA and PPTA certified organization aiming for FDA and EMA certifications. -Train and supervise lab specialists for adequate performance of lab techniques. - Work closely with team members to provide effective solutions to support business and quality objectives. - Ensure the lab establishes and maintains a calibration program for testing equipment that affect quality results. - Facilitate effective communication across… Show more -Supervise and improve operations in the QC Lab of an EDA and PPTA certified organization aiming for FDA and EMA certifications. -Train and supervise lab specialists for adequate performance of lab techniques. - Work closely with team members to provide effective solutions to support business and quality objectives. - Ensure the lab establishes and maintains a calibration program for testing equipment that affect quality results. - Facilitate effective communication across internal departments by trending and reporting data. - Ensure adherence to regulatory requirements, budgets, and schedules. - Establish and improve procedures and processes by addressing issues and risks. - Utilize proven employee management solutions to improve productivity and efficiency. - Ensure that all materials are ordered, that samples are handled correctly, and that lab time is allocated adequately. - Establish and maintain health and safety protocols. - Evaluate possible deviation detected during the process as well as to propose measures to correct and prevent redundant or new deviations. - Establish Validation plan for all the equipment and testing methods. - Review and approval of validation reports related to testing methods in use in Plasma testing Laboratory. - Establish a Proficiency Test program for the testing performed in the QC Laboratory. - Maintain updated the Technical Information of the Plasma Testing Laboratory and optimize the resources and testing process. - Maintain updated the Technical Information of the Plasma Testing Laboratory. - Participate and support Regulatory inspections and audits. - Evaluate Regulatory Inspections and audit reports and review of corrective and preventive actions derived from the observations found. Show less

QC Laboratory Section Head

• Jan 2020 - Jul 2023

Reporting directly to the QC manager and leading a team of 1 supervisor, 3 Analysts and 3 technicians - Day-to-day supervision of QC lab functions - Follow-up of analysis of raw materials, finished products and stability lots - Follow-up of Validation activities (Process, equipment, analytical validation and new line commissioning activities) - Review stability and process trends - Supervising analytical investigations and root cause analyses - Quality Auditing - Planning… Show more Reporting directly to the QC manager and leading a team of 1 supervisor, 3 Analysts and 3 technicians - Day-to-day supervision of QC lab functions - Follow-up of analysis of raw materials, finished products and stability lots - Follow-up of Validation activities (Process, equipment, analytical validation and new line commissioning activities) - Review stability and process trends - Supervising analytical investigations and root cause analyses - Quality Auditing - Planning of lab CAPEX and OPEX - Change management

Senior Quality Control Analyst

• Jul 2018 - Dec 2019

- Reporting directly to the QC manager and leading a team of 3 Analysts and 2 technicians - Day-to-day supervision of QC lab functions - Analysis of raw materials, finished products and stability lots - Follow-up of Validation activities (Process, equipment, analytical validation and new line commissioning activities) - Review stability and process trends - Analytical investigations and root cause analyses - Quality Auditing - Change management

Quality Control Analyst

• Jun 2015 - Jun 2018

Analysis of Raw Materials, Packaging Materials, Water Samples, Finished Products and stability testing

Masters Student

• Nov 2017 - Jun 2018

R&D Specialist

• Sep 2012 - May 2015

Method Development and Validation Specialist Method Development and Validation Specialist