Miguel Goni
Vancouver,BC
Summary
Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
10
10
years of professional experience
Work History
Validation Engineer
PISA Laboratories
02.2017 - 02.2022
- Performance Qualification of terminal sterilization process
- Developments of aseptic media fill
- Improved validation processes by developing and implementing risk-based strategies for equipment, systems, and facilities.
- Utilized statistical tools such as Six Sigma methodologies contributing to data-driven decision making during validation processes.
- Supported new product introductions by validating equipment, processes, software, and cleaning procedures as required.
- Optimized manufacturing efficiency through the development of robust process validation protocols and execution of performance qualifications.
Physicochemical Analyst
Collins Laboratories
04.2016 - 02.2017
- Performance of Dissolution profiles
- Performed chemical tests making qualitative and quantitative analyses of solid, liquid, and gaseous materials.
- Increased quality control compliance by conducting thorough data reviews and addressing discrepancies promptly.
- Operated laboratory equipment and prepared compounds and solutions to conduct tests.
- Performed analysis of pharmaceutical finished products using various methods to test for purity.
- Calibrated and maintained laboratory spectrometers and chromatographs.
Quality Control Analyst
Calidra Group
03.2012 - 04.2016
- Granulometrics Analysis
- Developed and maintained quality assurance procedure documentation.
- Performance of Phisicochemicals Analysis
- Elaborations of Reports on Dinamics AX System
- Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
- Maintained a safe working environment, adhering to safety regulations and proper handling of hazardous materials.
- Conducted data review and followed standard practices to find solutions.
Education
Diploma in Costumer Service -
Greystone College of Business and Technology
Barchelor Degree in Chemical Pharmaceutical -
CUCEI, Universidad de guadalajara
Guadalajara, Mexico01.2010
Technician Degree in Quality Control Chemical and enviroment -
Preparatoria #12
Guadalajara, Mexico01.2005
Skills
- Effective Communication
- Equipment Qualification
- Testing protocols
- Analytical Thinking
References
available upon request
Languages
English
Professional Working
Spanish
Native or Bilingual
Timeline
Validation Engineer
PISA Laboratories
02.2017 - 02.2022
Physicochemical Analyst
Collins Laboratories
04.2016 - 02.2017
Quality Control Analyst
Calidra Group
03.2012 - 04.2016
Diploma in Costumer Service -
Greystone College of Business and Technology
Barchelor Degree in Chemical Pharmaceutical -
CUCEI, Universidad de guadalajara
Technician Degree in Quality Control Chemical and enviroment -
Preparatoria #12