Albert Lugo Email & Phone Number

United States

Managed and ensured compliance with Customer Quality Engineering Requirements for the Infrastructure, Automotive, Defense & Aerospace Business Units.Site-wide management responsibility of CAPA, Change Control Board, Material Review Board, Quality Engineering Change Order Approval and LEAN A3 Continuous Improvement Systems.Site-wide implementation of ITAR.

• Lead Quality Assurance projects, initiatives and investigations for compliance and continuous improvements.Achievements:
• Lead QA Projects and initiatives such as: the Implementation of a Quality Council for the Functional Units, Change Control Auditing, QA approval of Technology and Engineering Procedures, and SAP CAPA implementation.
• Performed as Operational Excellence Specialist, leading & closing an average of three to four manufacturing investigations per week, with 33 % reduction in past due investigations and over $ 10 M in company savings.

• Lead the Manufacturing Site Team, for the introduction of Bifeprunox, a novel neuroscience product, from Solvay Pharmaceuticals, Europe, to Wyeth, Guayama, P.R.Achievements:
• Lead and accomplished the planning, budgeting, capital appropriation request, team recruitment, design of new facility, and the equipment specifications & procurement, in only four months.
• Lead the Site Team to accomplish the Process Development, Demonstration, Clinical and Registration batches, for nine different solid doses, and started Stability testing on time for NDA filing in Q1’06, in a record.
• The team received an Achieving Excellence Above and Beyond Award, in recognition of flawless implementation and performance that achieved business objectives, while exemplifying our Company Values.

• Lead the Manufacturing Site Team for the transfer of Rapamune (solid doses), from Wyeth Rouses Point, N.Y. to Wyeth, Guayama, P.R., reporting directly to the Vice-President and General Manager.Achievements:
• Lead the construction, commissioning, qualification and validation activities of the Rapamune 1 mg. Seal Coating, Sugar Coating and Active coating manufacturing processes, in less than a year.
• Within the second year, completed the validation of Rapamune 2 and 5 mg., and lead the team towards a successful FDA Pre-Approval Inspection and approval, for Rapamune 1 mg. and 5 mg coated tablet doses.

Lead the construction and commissioning phases for the Centrum and Caltrate manufacturing processes.

Lead FDA Compliance Gap elimination projects for the Engineering Department.

Bachelor, Electrical Engineering

Electrical Engineering