Laura Botta

Laura Botta Email and Phone Number

Miembro del Comite de Expertos de Aseguramiento de la Calidad @ SAFYBI
Buenos Aires, CABA, AR
Laura Botta's Location
Greater Buenos Aires, Argentina
Laura Botta's Contact Details

Laura Botta personal email

n/a
About Laura Botta

Chemist and Pharmacist with quite a lot of experience (33yrs) in the Pharmaceutical Industry. I worked in different positions (Quality Control, Quality Assurance, Production, Training, Technology) focused on improving Quality Systems and Production Efficiency for the firms I have worked with.Have strong skills to obtain results on time and in particular, before the planned dates.Experienced in creating systems for an excellent organization with special orientation towards the clients (both internal and external).Have a high degree of Leadership skills. I also function as a Mentor and Appraiser or Evaluator.Able to work with and manage people with different levels of education.Expertise in communication skills regarding the interfacing with different business units of the Corp. Group. Excellent level of oral and written communications in English.Competencies in Problem Identification, Strategic Thinking and Planning for Resolutions in order to obtain Continuous Improvements.Highly motivated with respect to New Projects and a Self-starter. Abilities: clear, patient, excellent oral and written communication skills.I proved my abilities with a very succesful result with the digitalization of different type of documents and the use of New Softwares Applications for 300+ people in 3 countries. also, I have improved the usage of New Doc System and facilitate groups during projects of expansions of health products manufacturing facitilies.Over 30 years of experience within Pharmaceutical Industry in several positions. Experience in Change Management, Training, Quality Assurance, Audits, Reg Affairs, Product Transfers, Imports & Exports Reg, Projects, Softwares implementation. FDA/Digemid/ Anvisa/ MHRA/ Other agencies Preparedness Training. Recruiting and preparing on boarding plans of more than 150 employees per year. Developing surveys. Designing of Training programs. Root Cause Analysis. Detection of training needs. Team working.

Laura Botta's Current Company Details
SAFYBI

Safybi

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Miembro del Comite de Expertos de Aseguramiento de la Calidad
Buenos Aires, CABA, AR
Website:
safybi.org
Employees:
58
Laura Botta Work Experience Details
  • Safybi
    Miembro Del Comite De Expertos De Aseguramiento De La Calidad
    Safybi
    Buenos Aires, Caba, Ar
  • Pint Pharma
    Head Of Qa
    Pint Pharma Oct 2024 - Present
    Argentina
  • Safybi
    Coordinadora Del Comité De Expertos De Aseguramiento De Calidad
    Safybi Jan 2024 - Present
    Argentina
  • Safybi
    Co-Coordinadora Del Comité De Expertos De Aseguramiento De Calidad
    Safybi Jan 2022 - Dec 2023
    Argentina
  • Safybi
    Vocal De Comisión Directiva
    Safybi Jan 2016 - Oct 2022
    Uruguay 469. Ciudad Autónoma De Bsas
    Hermosa experiencia con importantes colegas de la industria donde mejoré las habilidades interpersonales. Gran crecimiento personal nutrido por experiencias con otras visiones provenientes de otros laboratorios.
  • Safybi
    Miembro Del Comite De Expertos De Aseguramiento De La Calidad
    Safybi Jun 2020 - Dec 2021
    Argentina
  • Sinergium Biotech
    Head Of Qa Compliance
    Sinergium Biotech Mar 2024 - Oct 2024
    Garín, Provincia De Buenos Aires, Argentina
  • Catalent Pharma Solutions
    Quality Management Systems Head
    Catalent Pharma Solutions Oct 2021 - Dec 2023
    Argentina
    Team Leader Reporting to the Quality Director.Schedule and attending regulatory and client audits. Perform and report on deficiencies within the system during Internal Audits.Training and Documentation Managment.Evaluation of Change Control and verification of final activities related to Documentation and Training. Leading Green Belt projects.Quality unit approval of Documentation as SOPs, Methods and SpecificationsAlignment of documentation regarding New regulatory and… Show more Team Leader Reporting to the Quality Director.Schedule and attending regulatory and client audits. Perform and report on deficiencies within the system during Internal Audits.Training and Documentation Managment.Evaluation of Change Control and verification of final activities related to Documentation and Training. Leading Green Belt projects.Quality unit approval of Documentation as SOPs, Methods and SpecificationsAlignment of documentation regarding New regulatory and corporate polices requirementsParticipation in investigations that need a deep understanding of root cause analysis.Definition of corrective actions regarding methods and manpower.Implementation of New Quality softwaresPresentation of Quality MetricsDeveloping programs for New hires.Mentoring and corporate cross Training.Assesment during accidents related to people behaviour. Show less
  • Catalent Pharma Solutions
    Cw Latam Administrator
    Catalent Pharma Solutions Jun 2004 - Nov 2023
    Argentina
    Since 2004: Argentina AdminSince 2006: Argentina-Brazil AdminSince 2011: Argentina-Brazil-Uruguay Admin
  • Catalent Pharma Solutions
    Technical Training Head
    Catalent Pharma Solutions Sep 2004 - Oct 2021
    Argentina
    Team Leader reporting to the Operations Director.Provide direct support for audits/ regulatory inspections.Administer, act as Argentina/Brazil Project Leader for rollout and maintenance of EduNeering ComplianceWire System.Keep Senior Management informed as to the site training needs/trends. Participate in Corporate/Global Projects within Intl Experts Teams, establishing guidelines/assessing from the point of view of the Training of the personnel.Develop/Conduct cGMPs… Show more Team Leader reporting to the Operations Director.Provide direct support for audits/ regulatory inspections.Administer, act as Argentina/Brazil Project Leader for rollout and maintenance of EduNeering ComplianceWire System.Keep Senior Management informed as to the site training needs/trends. Participate in Corporate/Global Projects within Intl Experts Teams, establishing guidelines/assessing from the point of view of the Training of the personnel.Develop/Conduct cGMPs Training Program, complying with Regulatory requirements. Communicate effectively with respect to the current/new requirements/training courses and provide follow-up.Evaluate training requirements for Catalent Argentina’s personnel. Manage the activities of the Training Department, establish guidelines, priorities and requirements and track training projects and initiatives in order to cover all of the Catalent Argentina’s training needs. Show less
  • Safybi
    Coordinadora De Comité Cientifico - Congreso Expofybi 2017
    Safybi Dec 2016 - Oct 2017
    Centro Costa Salguero
  • Safybi
    Colaborador En Comision Directiva
    Safybi Feb 2014 - Jan 2016
    Australia
    La Asociación Argentina de Farmacia y Bioquímica Industrial (SAFYBI), es una entidad que nuclea a los profesionales farmacéuticos y bioquímicos que desempeñan su labor en las industrias farmacéutica, bioquímica, farmoquímica, productos médicos, cosmética, alimentaria, veterinaria y anexas, como así también del ámbito hospitalario. Más de 900 profesionales y empresas forman actualmente parte de la institución como socios activos, socios estudiantes, socios adherentes y socios adherentes… Show more La Asociación Argentina de Farmacia y Bioquímica Industrial (SAFYBI), es una entidad que nuclea a los profesionales farmacéuticos y bioquímicos que desempeñan su labor en las industrias farmacéutica, bioquímica, farmoquímica, productos médicos, cosmética, alimentaria, veterinaria y anexas, como así también del ámbito hospitalario. Más de 900 profesionales y empresas forman actualmente parte de la institución como socios activos, socios estudiantes, socios adherentes y socios adherentes cooperadores.Como socio activo, mi mision es:-Promover el interes por la asociacion y las relaciones profesionales.-Colaborar con la agenda de cursos y congresos.-Brindar conocimientos y experiencias para mejora de la organizacion.-Compartir lo aprendido con mis colegas. Show less
  • Safybi
    Secretaria De Comité Científico Del Congreso
    Safybi Mar 2015 - Aug 2015
    Las principales responsabilidades son:• Confección de cartas de invitación en castellano e inglés.• Diagramación de agenda de 150 conferencias en 5 auditorios por 4 días coordinada con 8 Coordinadores de Comité de Expertos.• Recolección de la información como CVs, fotos, contenidos de los disertantes.• Seguimiento del presupuesto por traslados y estadías de disertantes extranjeros invitados.• Coordinación de programa preliminar y final para entregar en el congreso.*… Show more Las principales responsabilidades son:• Confección de cartas de invitación en castellano e inglés.• Diagramación de agenda de 150 conferencias en 5 auditorios por 4 días coordinada con 8 Coordinadores de Comité de Expertos.• Recolección de la información como CVs, fotos, contenidos de los disertantes.• Seguimiento del presupuesto por traslados y estadías de disertantes extranjeros invitados.• Coordinación de programa preliminar y final para entregar en el congreso.* Edición de contenidos en página web. Show less
  • Aeromedical Distributor
    Directora Técnica
    Aeromedical Distributor Jun 2015 - Sep 2015
    Gerenciamiento del sistema integral de gestión de calidad. Gestión y registro de Productos medicos.
  • Infinity Insumos S.R.L.
    Directora Técnica
    Infinity Insumos S.R.L. Sep 2014 - May 2015
    Asesorías de calidad para productos médicos implantables
  • Cardinal Health
    Technical Training Head
    Cardinal Health Sep 2001 - May 2004
    RPScherer was bought by Cardinal Health. Then, PT&S Division (a part of Cardinal Health) was sold and re-named as Catalent Pharma Solutions.Main goal: Design of the training system in order to be prepared for FDA and EMA certifications
  • 3M Pharmaceuticals
    Quality Assurance Coordinator
    3M Pharmaceuticals Jun 1998 - Sep 2001
    Compliance activities: ISO9000 Internal Auditor . Writing methods and specifications of APIs, aerosol, packaging, medical devices, etc aligned with international guidelines. Audits of services and raw material suppliers.Regulatory affairs activities : dossier review, embassy register for import and export, ANMAT taxes payments for medical devices and pharmaceutical productsMain goal: design of a new software for documentation control.
  • Roemmers
    Cgmp Training Coordinator
    Roemmers 1997 - Jun 1998
    Training of GMPs in order to change minds and obtain FDA and ISO certifications of the new site called ROEMMERS Pharma 2000.
  • Investi Farma
    Quality Control Analyst
    Investi Farma 1992 - Jun 1998
    Performing of chemical analysis of more than 1000 ingredients, inluding APIs.Using different types of instruments as follows: KF, MS, HPLC, NIR, FTIR, IR, GLC, UV, micro and IR balances, etc

Laura Botta Skills

Entrenamiento Asuntos Normativos Liderazgo De Equipos Multidisciplinarios Poe Cambio Organizacional Training Fda Gmp Acciones Correctivas Y Preventivas Control De Cambios Technical Documentation Pharmaceutical Industry Control De Calidad E Learning Auditing Change Management Strategic Communications Regulatory Affairs Quality System Root Cause Problem Solving Organizational Behavior Documentum Gmp Compliancewire Cross Functional Team Leadership Trabajo De Grupo Fda

Laura Botta Education Details

Frequently Asked Questions about Laura Botta

What company does Laura Botta work for?

Laura Botta works for Safybi

What is Laura Botta's role at the current company?

Laura Botta's current role is Miembro del Comite de Expertos de Aseguramiento de la Calidad.

What is Laura Botta's email address?

Laura Botta's email address is la****@****.com.ar

What schools did Laura Botta attend?

Laura Botta attended Universidad Kennedy, Universidad Tecnológica Nacional, Cofybcf, Escuela Argentina De Pnl & Coaching, Safybi, Universidad Tecnológica Nacional, Universidad Tecnológica Nacional, Universidad De Belgrano, Universidad Atlántida Argentina, Escuela Técnica Otto Krause, Universidad De Buenos Aires.

What are some of Laura Botta's interests?

Laura Botta has interest in Social Services, Children, Education, Health.

What skills is Laura Botta known for?

Laura Botta has skills like Entrenamiento, Asuntos Normativos, Liderazgo De Equipos Multidisciplinarios, Poe, Cambio Organizacional, Training, Fda Gmp, Acciones Correctivas Y Preventivas, Control De Cambios, Technical Documentation, Pharmaceutical Industry, Control De Calidad.

Who are Laura Botta's colleagues?

Laura Botta's colleagues are Carlos Chavez, Sebastian Guillermo Martinez, Gabriela Roth, Roberto Oscar Arias, Belen Parodi, Dra Cecilia Sobrero Sobrero, Federico Montes De Oca.

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