Toki Nishide
Food Chemestry
Mexico
Summary
To develop professionally under the ethics, responsibility and organizational culture, applying knowledge and skills to
provide high quality and high satisfaction
Dynamic professional with extensive experience at Fermic S.A. De C.V. in chemical documentation and regulatory compliance. Proven leadership as a Lead Auditor, adept at managing master documents and navigating complex regulations. Strong analytical skills and a collaborative spirit drive successful project outcomes in high-pressure environments.
Overview
8
8
years of professional experience
5
5
years of post-secondary education
2
2
Certifications
4
4
Languages
Work History
Chemical Documentation
Fermic S.A. De C.V.
Mexico City
08.2018 - Current
- Experience in applicable national regulations and quality management systems for the pharmaceutical-chemical and food industry.
- National Regulations NOM-164-SSA1-2015, NOM-SSA1-059
2015, NOM-251-SSA1-2009. - International Standards: USP/EP, FCC, ISO 22000, 9001,
14001, 45001. FDA and ICH Q7 and EPA. - Management of master documents including elaboration, approval and maintenance of Dossier in accordance with the applicable regulations of pharmaceutical products market (US, EU, Canada, Brazil and India).
- Management of master documents including elaboration, approval and maintenance of Dossier in accordance with the applicable regulations of Veterinary Pharmaceutical products (US, Canada and Australia).
- Receipt of audits from national and international regulatory entities such as COFEPRIS (3 approval cycles) and FDA (2 approval cycles).
- Lead Auditor since 2020.
- Preparation of technical information for the different human and veterinary pharmaceuticals, industrial and food/feed products.
- Management and administration of the electronic document system and change control.
- Management of master documents.
- Organization of information under the study, analysis, interpretation and classification of data,
- Internal auditor.
- Self-motivated, with a strong sense of personal responsibility.
- Excellent communication skills, both verbal and written.
- Proven ability to learn quickly and adapt to new situations.
- Skilled at working independently and collaboratively in a team environment.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Paid attention to detail while completing assignments.
Investigator
UNAM
Mexico City
04.2017 - 08.2018
- Prediction, synthesis, processing and calibration of photovoltaic cells and flow batteries. Project in collaboration with Harvard University.
- Collected, analyzed and interpreted information, documentation, and physical evidence associated with investigations.
- Assisted in the development of investigative strategies, resulting in more efficient case resolutions.
- Maintain a professional tone.
- Documented findings and prepared detailed reports.
Education
Bachelor of Science - Chemical Food
Universidad Nacional Autónoma De México
Mexico City 08.2012 - 04.2017
Skills
Friendly, positive attitude
Teamwork and collaboration
Computer skills
Customer service
Organization and time management
Calm under pressure
Team management
Accelerated learning
Analytical skills
Adaptation to work teams
Order and discipline
Initiative and leadership
Positive attitude
Handling of chemical products
Compliance with the standard
Certification
Food Additives Training - 160 hours
Timeline
Project Managment Training-160 hours
08-2019
Chemical Documentation
Fermic S.A. De C.V.
08.2018 - Current
Food Additives Training - 160 hours
08-2018
Investigator
UNAM
04.2017 - 08.2018
Bachelor of Science - Chemical Food
Universidad Nacional Autónoma De México
08.2012 - 04.2017
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