María Susana Vásquez Castro
Pharmacist
Costa Rica,Alajuela
Summary
Determined Pharmacist with dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills. Experience in Research and Development, Project Management, Quality Assurance and Pharmaceutical Manufacturing.
Overview
5
5
years of professional experience
10
10
years of post-secondary education
5
5
Certifications
1
1
Language
Work History
Quality Assurance Specialist/Authorized Person
Bayer Medical
04.2022 - Current
- Main Quality responsible with production and engineering to ensure entire operational readiness for manufacturing process and adequate technology transfer process, this includes creating of standard operating procedures (review of 100+ SOPs), systems testing, coordinate transfer of knowledge of operative personnel, support on risk management and execution of training batches (15+ batches), etc
- Manage Quality Assurance Inspector and trainer of shift
- Coordination, execution and approval of quality issues investigations and corrective and preventive actions related to product
- Develop and implement core process of Quality Management System such as operative training program, batch release process for raw materials, packaging materials and manufacturing batches, management of cleanroom and gowning areas (10+ documents)
- Perform batch records and quality control results evaluation and release of bulk batches
- Assist on preparation and hosting of internal and external audits.
- Educated employees on specific QA standards and confirmed maintenance of standards
- Recorded findings of inspection process, collaborating with quality team to implement corrective actions
- Analyzed quality and performance data to support operational decision-making
University Lecturer
Facultad de Farmacia, Universidad de Costa Rica
03.2020 - 12.2022
- Courses: Pharmaceutical Technology I, Laboratory of Drug Analysis III, Laboratory of Pharmaceutical Physicochemistry I and Laboratory of Pharmaceutical Physicochemistry II.
- Conducted ongoing assessment of student progress, adjusting teaching strategies as needed to maximize learning potential
- Designed assessments that accurately measured student understanding of key concepts while minimizing opportunities for cheating or plagiarism
- Created and designed quizzes, tests and projects to assess student knowledge
- Conducted engaging in-class discussions to facilitate learning and encourage participation
Research and Development Scientist
Laboratorios LISAN S.A.
07.2019 - 03.2022
- Lead, manage and execute projects assigned for development of complex pharmaceutical, natural, and cosmetic products and its manufacturing processes, including design input requirements for product, design test methods and quality specifications according to regulatory requirements, design and execute product formulation tests and lead stability studies execution
- Procure and test new raw materials and packaging materials
- Design it’s quality specifications and requirements
- Propose and implement improvements in existing complex manufacturing processes applying deep research analysis to understand physical chemistry and bio pharmaceutical effect of formula
- Successfully designed and developed 6 products
- Design and implementation of different project management tools for improving and making more efficient and assertive RDI process such as: current technical feasibility study, current economic feasibility study, current schedule for project management, current documents used to define product profile and prioritization of its attributes so that design and development are focused on what will make product profitable
- Provide training to stakeholders involved
- Plan, lead and execute transfer of new products through development and implementation of transfer protocol designed applying risk analysis and quality tools (FMEA, Ishikawa, Root cause analysis, Statistical analysis and statistical sampling plans, etc)
- Successfully transferred 3 products and trained people involved in manufacturing process
- Teamwork with different areas such as Production Department, Quality Control and Quality Assurance in solving problems and investigation of complex compliance issues of final products, raw materials, package materials and others (e.g., CAPA, non-conformances, deviations, investigations) and make constructive recommendations based on cause.
Student Intern
Laboratorios LISAN S.A.
01.2019 - 06.2019
- Development of final graduation project in Production and Research, Development: Application of Quality by Design (QbD) in th reformulation of an immediate release coated tablet at Laboratorios Lisan S.A
- Trainee in Design of Experiments (DoE)
- Supervise manufacturing processes and resolution of deviations and complex investigations.
- Applied theoretical knowledge gained from coursework to real-world situations within the internship setting for improved understanding of industry practices
- Developed time-management skills through balancing multiple assignments while consistently meeting deadlines during the internship period
- Conducted industry research to support team decision-making processes and contribute to successful project outcomes
- Demonstrated adaptability by learning new software programs and tools quickly, enhancing overall efficiency within the intern role
Education
Master’s Degree in Industrial Engineering -
Universidad De Costa Rica
San Pedro, SJ 01.2022 - Current
Project Management Technician -
Instituto Tecnológico De Costa Rica
San Pedro, SJ 04.2020 - 05.2021
Pharmacy Degree -
Universidad De Costa Rica
San Pedro, SJ 03.2013 - 08.2019
Skills
Research experience
undefinedCertification
Implications and interpretation - Medical devices according to the standard ISO 13485:2016, Control, Instituto de Normas Técnicas de Costa Rica (INTECO),
Legal Requirements
Passport and USA Visa B1/B2 up to date
Timeline
Principles And Practice of Clinical Research
07-2024
Quality Assurance Specialist/Authorized Person
Bayer Medical
04.2022 - Current
Implications and interpretation - Medical devices according to the standard ISO 13485:2016, Control, Instituto de Normas Técnicas de Costa Rica (INTECO),
03-2022
Master’s Degree in Industrial Engineering -
Universidad De Costa Rica
01.2022 - Current
Scrum Master Certified, ScrumStudy
04-2021
Statistical Processes Control, Instituto de Normas Técnicas de Costa Rica (INTECO)
03-2021
Project Management Technician -
Instituto Tecnológico De Costa Rica
04.2020 - 05.2021
University Lecturer
Facultad de Farmacia, Universidad de Costa Rica
03.2020 - 12.2022
Research and Development Scientist
Laboratorios LISAN S.A.
07.2019 - 03.2022
Student Intern
Laboratorios LISAN S.A.
01.2019 - 06.2019
Leadership Program of Universidad de Costa Rica: Module I Self-leadership and Module II Leading others, Universidad de Costa Rica
02-2014
Pharmacy Degree -
Universidad De Costa Rica
03.2013 - 08.2019
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