Sobre Mi:
Professional Path
My experience within the Pharmaceutical and Manufacturing Industry includes over 22 years of experience. This experience includes work in the field of chemistry, process design development and validations, environmental, Quality Control Engineer, Six Sigma, CI4-Plus, equipment installation and validation, analytical investigations of deviation in the laboratory and manufacturing also technical writing and documentation. At the present my position is as Quality Control Laboratory Instrument Supervisor and Computer System Validator.
Some of the instruments equipment that I have worked with includes Quality Control Laboratory Computerized Systems such as Millenium, Nugenesis, TurboChorm, Chemserver UNIX, Agilent Chemstation, Omnic FT- IR, SX UNIX FT- IR, Zymark Laboratory Robotic Unit PY systems, TrackWise, SAP CAPA Corrective and preventive Actions and many others. I have also worked with the implementation, troubleshooting configuration, and supported the validation activities for Gxp Systems. My experience also includes the development and reviewing of protocols, procedures and guidelines for equipment & computer validation plans.
My responsibilities and duties included the development, validation, implementation and troubleshooting of chemical methods, using new technology such as FT-IR with the microscope, DSC (Differential Scanning Calorimeter), TGA (Thermo Gravimetrical Analysis), Particle Size Analyzer Horiba, Galai-Brinkmann and Malvern Matersizer, and near infrared. I have also authored written implemented a troubleshooting guide for A visual Basic software.
I was appointed to be the Site Leader for the Y2K project for BMS Barceloneta PR and while working on this assignment. I was asked to lead the PR team. I was also appointed to lead the project of Electronic Record and Electronic Signature, CFR part11 for BMS Barceloneta PR, and achieve regulatory compliance.
Some of my accomplishments include the development of a new department by uniting technical services with a previously created validation department. During 1990-1997.
I was given a Presidential Award of $5000 for saving 49 products lost from being destroyed.
Información de proyecto:
Microbiology DAN RNA rececuency