Jonathan Saavedra Email & Phone Number

United States

Paris, France, FR

· Implementation of contamination control strategies in the different stages of the processes of each of the sites (Antigens and FF&P).· Attend investigations related to sterility assurance (environmental excursions, contamination problems).· Review documents related to commissioning, qualification, process validation, risk assessment and regulatory.

Lawrence Township, NJ, US

As Manager, Quality Control Microbiology CAR T in Bristol Myers Squibb, I will have the following responsibilities:Manager of Microbiological Quality Control Laboratory:- Support in sterile compounding and filling operations.- Support in regulatory audits (FDA, MHRA, PMDA).- Quality system management: SOPs, change control, deviations, CAPAs, and risk.

Paris, France, FR

• Ensure the delivery of 100% analytical results of Quality Control Laboratory to meet the production schedule.
• Provide and manage the material and human resources necessary to guarantee that the analyzes carried out in the laboratory are reliable and complete; to ensure the quality of flu vaccine.
• Monitoring and implementation of corrective and/or preventive actions derived from deviations, audit observations, results out of specification and/or out of trend to comply with current regulations.
• Ensure compliance with internal policies (SANOFI global), national regulation (COFEPRIS, NOM-059, NOM-073, NOM-035, FEUM) and international standards (FDA, EMA) related to Quality Control in the international.

Guadalajara, Jalisco, MX

• Redesign the quality management system in the microbiology laboratory as a plant remediation project; in order to comply with internal policies and national regulations (NOM-059, NOM-073, FEUM) to achieve the reopening.
• Ensure the microbiological quality of raw materials, finished product, product stability and critical systems in the oncological sterile plant; Leading a team of 22 people, 2 heads with 10 reports in charge.
• Provide and manage the material and human resources necessary to guarantee that the microbiological analyzes developed in the laboratory are reliable and complete; with the purpose of ensuring the microbiological.
• Monitoring and implementation of corrective and/or preventive actions derived from deviations, audit observations, results out of specification and/or out of trend in order to comply with current regulations.
• Develop activities based on Safety and Environmental policies and procedures that contribute to achieving organizational objectives.
• Removal of closure seals in the Microbiology laboratory and start-up of the microbiology laboratory with the authorization of the regulatory entity in Mexico (COFEPRIS).

Brentford, Middlesex, GB

• Ensure compliance with internal policies (GSK Global), national regulations (COFEPRIS, NOM-059, NOM-073, NOM-035, FEUM) and international standards; such as USA (FDA), Colombia (INVIMA), Brazil (ANVISA) related to.
• Responsible for identifying and mitigating microbial risks in products manufactured in oral solids, liquids and cephalosporin plants; as well as critical services in each plant (purified water, compressed air and.
• Monitor compliance with internal, corporate and supplier audits, in order to ensure their execution in a timely manner.
• Attended audits from different regulatory bodies (COFEPRIS, INVIMA, NOVARTIS, GSK global) to obtain the GMP (Good Manufacturing Practices) certificate.
• I complied 100% with the implementation and closure of corrective and/or preventive actions derived from deviations, risks, audit observations, results out of specification and/or out of trend within the established.
• Standardize the delivery time of results from the microbiology laboratory to comply with the manufacturing program 100%.

Lomas De Reforma, Distrito Federal, MX

• Responsible for the development, implementation and innovation of the quality management system in the physicochemical, microbiology and vivarium laboratories; to guarantee that products, critical systems and.
• Lead a team of 15 collaborators located in 3 areas (physicochemical laboratory, microbiology laboratory and vivarium) responsible for performing laboratory analyzes to generate reliable and timely results, meet.
• Attended audits of different regulatory bodies (WHO, FDA, COFEPRIS, INVIMA, Dutch Ministry of Health) to obtain the GMP (Good Manufacturing Practices) certificate, implementing and closing the corrective and/or.
• I transferred, without interruption of activities, the operation of the Tlalpan plant to the new laboratory in the Toluca 2000 industrial park, achieving the analysis and compliance with quality and safety standards..
• We achieved approval of the new Quality control laboratory and Biotechnology plant by the regulatory entities of Mexico (COFEPRIS) and the USA (FDA).
• I collaborated with a multidisciplinary team in the preparation of the dossier for registration in the USA. of the biotechnological products ANASCORP and ANAVIP, until obtaining approval for the sale and distribution.

Maestría, Calidad Y Estadística Aplicada

Dirección Farmacéutica, Farmacia

Químico Farmacéutico Industrial, Farmacia