Expert Details
Validation
ID: 726049
Puerto Rico
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 2000 | Degree: MBA | Subject: Engineering Management | Institution: Politecnhic University of Puerto Rico |
| Year: 1997 | Degree: BS | Subject: Industrial Chemistry | Institution: University of Puerto Rico |
| Year: | Degree: MS | Subject: Manufacturing Competitiveness | Institution: Politechnic University of Puerto RIco |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2003 to Present | Employer: Undisclosed | Title: Validation Consultant | Department: |
Responsibilities:He is responsable to manage validation projects. Supervise resources acting as a Project Manager. He is also responsible to develop and execute validation protocols, reports and investigation reports when required. |
|||
| Years | Employer | Title | Department |
| Years: 2002 to 2003 | Employer: Foth & Van Dyke | Title: Lead Validation Specialist | Department: Validation |
Responsibilities:He was responsible to establis customer relationships with clients.He was responsible to supervize Validation Specialists. He was responsible to validate equipment, facilities and utilities according to clients needs. |
|||
| Years | Employer | Title | Department |
| Years: 1998 to 2002 | Employer: Pharmacia formaly Pfizer | Title: Process Specialist | Department: Manufacturing |
Responsibilities:He was responsible to create Investigation Reports due to failures during the manufacturing and packaging process.He was responsible to validate equipment, facilities and utlities. |
|||
Career Accomplishments
| Associations / Societies |
|---|
| ACS, ISPE |
| Licenses / Certifications |
|---|
| Puerto Rico Chemical Liscense |
Additional Experience
| Training / Seminars |
|---|
| He was invited to create presentation and teach to some validation activities of the Polytechnic Univertisy of Puerto Rico. He was also part of a consulting firm teching validation techniques to validation personnel. |
| Vendor Selection |
|---|
| He was in charge of creating new vendors relatinship |
Language Skills
| Language | Proficiency |
|---|---|
| Spanish | Native language |
Fields of Expertise
21 CFR Part 11, analytical chemistry, bulk pharmaceutical chemical manufacturing, drug regulation, FDA food labeling regulation, FDA limulus amebocyte lysate test regulation, Food and Drug Administration regulation, generic drug manufacturing, investigational drug, investigational drug procedures, pharmaceutical capsule, tablet manufacturing, active pharmaceutical ingredient