Jorge Aponte
Associate Director Validation Services at Boehringer Ingelheim
- Role
- Associate Director Validation Services at 勃林格殷格翰
- Location
- Columbus, OH, US
- LinkedIn followers
- 500 followers
Experience
Associate Director Validation Services
May 2015 — Present
As Validation servives AD my goal is to maintain and support the areas of manufacturing, laboratory, Engenieer ensuring that Validation, Compliance and Quality requirements and with safety standards,environmental are met. Responsible for the approval and completion of validationdocuments which are in compliance with regulatory guidelines and businessrequirements for equipment, utilities, facilities, and process control systems.Responsible for controlling the risks associated with the regulatory requirements ofvalidation and direct the Validation Services Department in effectively interpretingand deploying the regulatory requirements through appropriate documentation includingplanning, risk analysis, testing strategies, periodic review and validationassessments. This position provides both long term and short term strategic direction and ensures alignment to site goals for computerized systems validation andequipment qualification. Responsible to support site initiatives such as zerodefects andbehaviorable based compliance by providing resources for launch at willteams, conducting business reviews to drive site objectivesand departmentalcommunication. This position is responsiblefor a cost center budget in excess ofthree million dollars. This position also has the responsibility to develop futureleaders within the organization and support the compliance services organization.This position assists in maintaining the Dynamic Compliance Model concept andproviding value propositions and guidance to local, BIRI and RLI, and global,International Computer Systems Validation and Compliance Working Group, quality andcompliance initiatives.
Education
University of Puerto Rico-Mayaguez
Bachelor's degree, Chemical Engineering
1985 — 1990
Skills
- Value Stream Mapping
- Process Improvement
- Six Sigma
- Manufacturing
- Lean Manufacturing
- V
- Product Development
- Gmp
- Continuous Improvement
- Pharmaceutical Industry
- Sop
- Fda
- Strategy
- Cross-Functional Team Leadership
- Validation
- Project Management
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