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 aspects related to sterility assurance.· Evaluate and implement best practices on issues related to the control of contamination from the different Sanofi sites.· Evaluate the microbiological impact, particles and bacterial endotoxin on materials and consumables related to the manufacturing processes at each of the sites.· Implementation of the qualification program for personnel associated with sterility assurance.· Evaluate the introduction of new technologies related to sterility assurance.· Participate in audits/inspections/visits, focused on sterility assurance aspects.

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 assessments handling.- Providing statistic control charts, action and alert limits. Microbiology laboratory testing data and trending.- Support validations/suitability studies in microbiological laboratory area.- Providing mentoring and coaching, influencing, negotiating and personal interaction skills.- Resource management and planning activities.

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 pharmaceutical industry.

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 of the laboratory with the authorization of the regulatory entity in Mexico (COFEPRIS).•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 quality of the products manufactured in the oncological sterile plant.•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).•I participated in the multidisciplinary group in charge of designing the new facilities and purchasing equipment for the new Quality Control laboratory.•Instructed and guided my team for the implementation of continuous improvement tools (Lean Manufacturing, 5's, Kanban, Problem Solving, Gemba Walk) in the Microbiology laboratory.•Managed the validation of analytical methods (microbial limits, sterility test, endotoxin quantification, antibiotic potency) for the manufacturing of pilot batches in the oncological sterile plant.

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 microbiological control in the international pharmaceutical industry.•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 ambient air) with the establishment of continuous monitoring plans in order to guarantee continuity in the supply chain and compliance with good laboratory practices and good practices. of manufacturing.•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 Lead time.•Standardize the delivery time of results from the microbiology laboratory to comply with the manufacturing program 100%.•Managed the optimization of expenses in the purchase of supplies for the laboratory, achieving savings of 20%.•Implementation of continuous improvement tools such as: TIER, 5's, Kanban, Problem Solving, Budget Control, Gemba Walk in the microbiology laboratory; with which problems were resolved in a faster and more systematic way.•Managed the validation and transfer of microbiological analytical methods to a third-party laboratory; as part of the GSK Xochimilco plant closure project.

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 analytical processes comply with national regulations (COFEPRIS, NOM-059, NOM-073, NOM-035, FEUM) and international standards; such as the U.S. (FDA), Colombia (INVIMA), Holland and thus achieve the release of product on time and based on demand generation.•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 expiration dates and product launches, reduce cycle times .•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 preventive actions derived from each audit within the established Lead time.•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. Laboratory equipment and self-contained areas were transferred and qualified, this represented continuing the on-time delivery of the products required in the planning program to provide continuity to the supply chain.•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 of both medicines in the American Union.

Maestría, Calidad Y Estadística Aplicada

Dirección Farmacéutica, Farmacia

Químico Farmacéutico Industrial, Farmacia