MFG, Quality, Technology Transfer & Validation Specialist

OBJECTIVE: Seeking to obtain a position in the quality, technical, validation; technology transfer or related area in a progressive company with strong vision toward the future; where I can share my knowledge and experience, and at the same time acquiring new skills that will benefit your company; all based on teamwork.

EDUCATION: University of Puerto Rico Mayagüez, P.R.

B.S., Sciences (Biology/Chemistry).

University of Puerto Rico Medical Sciences Campus (School of Public Health).

Master Degree in Environmental Sciences. Thesis: “Biochemistry and Monitoring of Heavy Metals in Sea Water "Jobos" Bay, Guayama, Puerto Rico.

QUALIFICATIONS: Trained and experienced on Validation, Start-Up, Equipment Evaluation, Selection and Commissioning. Also extensive knowledge on Technical Investigations and Product/Process Development/Optimization. Know-how and experience in administrative techniques, Vendor qualifications, MRO and Raw Materials Purchasing.

Knowledge of industrial engineering techniques and its applications. Oversee and provide input on quality-related issues associated with maintenance and calibration of equipment and utilities serviced. Equipments IQ, OQ’s and PQ’s including computer system validations (211 CFR, Part 11). Responsible for the trouble shouting and failure investigation teams. Assist Quality Assurance during FDA and corporate inspections. Packaging process validation of solid dosages, bottles & blisters. Support of Developmental Research Review and approve SOPs, validation protocols, change control documents and investigations associated with Process Failure. Extensive auditing and compliance experience in cGMP's, FDA regulations, OSHA regulations and ICH guidelines (QSEM). Work effectively under pressure. Develop warm, yet professional, relationship with most peers and employees.

EXPERIENCE:

2006-2009: Andrx Pharmaceuticals/Watson Laboratories (Fort Lauderdale, Florida)

Senior Process Validation Scientific:

Monitor and executed manufacturing process validation. Assure the manufacturing process and related documentation comply with cGMP’s, DEA, OSHA regulations and ICH guidelines. Write and execute process validation protocols and reports. Design and approved all process validation related procedures. Failures & Investigation teams for develomental and process validation execution. Subject Matter expert during FDA inspections. Supervisor to Juniors and Technician personnel.

Acomplishment: Proactively the validation team created a “pre-validation assesment” SOP and documnetation that was approved and executed before process validation. The inspection team used these assesments in cunjuctions with the validation packages and submmited to the FDA. As a results of this “quality by design (QbD)” approach, the site regulatory status of OAI (Official Action Indicator) was removed by FDA.

2004-2006: Valeant Pharmaceuticals (Humacao, P.R.)

Technology Transfer Specialist:

Coordination of and responsible of all New Molecules transfers from Research & Development either bench/pilot size to the manufacturing site. In charge of develop manufacturing process and to supply clinical studies. New products team leader in all aspect of product transfer. Failures & Investigation team’s for current and new products transfer projects. Activities included SOP's and optimizing manufacturing instructions design. Report to technical director level the transfer cycle up to completed manufacturing process validation and start up activities.

2002-2004 Lilly Pharmaceuticals (Lilly Del Caribe):

Senior Technical Services & Validation Representative:

In charge of all Technology Transfer of manufacturing process from R&D/Sites or Site/Site. In Charge of Clinical lots manufacturing. New products team leader in all aspect of product transfer. Deviations investigation teams participant for the transfer project. Manage validation and start up activities, including SOP's and manufacturing instructions.

1995-2002 Warner Lambert Inc. /Pfizer Inc. Manufacturing Technology Department

Senior Pharmaceutical Technologist:

In charge of all Technology Transfer of manufacturing process from R&D/Sites or Site/Site. Manage validation and start up activities, including SOP's and manufacturing instructions (batch cards instructions design). Equipments IQ, OQ’s and PQ’s including computer system validations (211 CFR, Part 11). Responsible for the trouble shouting and failure investigation teams. Assist Quality Assurance during FDA and corporate inspections. Evaluation and supervising of department Juniors and Technicians. Budget and approval for out site Validation Contractor. Administrative activities.

Staff Pharmaceutical Technologist:

Responsible for coordination and implementation of validation projects. Validation of Plant Critical Systems (HVAC, DC, Compressed Air, Vacuum, Steam, Purified, Hot, Potable and Chilled Water etc. Validation and implementation of cleaning processes process improvements IQ/OQ's and process validation. Preparation of project schedules and cost tracking.

CERTIFICATION PROGRAM DURING CONSENT DECREE STATUS:

1993 – 1995

In charge of coordinating all activities pertaining to qualification of equipment, utilities and manufacturing process in a timely basis, assuring compliance with GMP’s, OSHA regulations and Warner Lambert Certification Program in reference to the consent decree status.

1993-1994 Warner Lambert Co. Manufacturing Department:

Process Control:

Responsible for all Manufacturing troubleshooting. Coordination of the Technology Transfer with Pharmaceutical Technology and R&D. Manufacturing and Packaging cost effective process optimization toward company standards.

1991-1993 Warner Lambert Co. Pharmaceutical Technology Departments:

Jr. Pharmaceutical Technologist:

Responsible for coordination and implementation of validation projects. Duties include preparation and implementation of installation, operational and performance qualification protocols for facilities, equipment, process and automated control systems, SOP generation and training, as well as preparation of project schedules and cost tracking.

1987-1991 Center for Energy and Environmental Research (University of Puerto Rico)

Laboratory Technician II

Responsible for the Analysis of water and soil samples via: AA, HPLC and GC. In charge of Quality on the Terrestrial Ecology Division Analytical Laboratory Investigation activities: Paper: Nitrogen Dynamics in the Soils of Two Forest in Puerto Rico: A comparative Study.

Efficient in multi-projects environment and capable of supervising technical and manufacturing personnel. Computer literate, fully bilingual, knowledge in all common word processing, spreadsheets, statistical or presentation software’s.

HIGHLIGHTS:

• Computer Systems Validation & Electronic Records and Electronic Signatures. 21 CFR Part 11. The Center for Professional Advancement - New Jersey.

• FDA Interaction, Warner Lambert, Inc and Valeant Pharmaceuticals.

• FDA Enforcement Trends for Cleaning Validation, Safety Research.

• Clean manufacturing for Real World Applications, Clean room Services.

• Pharmaceutical Packaging Line Validation: Practical Applications, Melvin Communications.

• Applied Polarized Light Microscopy: McCrone Research Institute.

• Ethics, Warner Lambert, Inc; Lilly del Caribe, Valeant Pharmaceuticals and Watson Labs. Florida.

• Kepner Tregoe, Problem Solving/Decision Making, Warner Lambert, Inc.

• Trainer the Trainer, Warner Lambert, Inc. Lilly Del Caribe, Valeant Pharmaceuticals and Watson Labs. Florida.

• Performance Management System, Warner Lambert, Inc.

• High Performance Training, High Performance.

• Qualification/Validation of Pharmaceutical Processes and System II Solid Dosage Forms, The Center for Professional Advancement - New Jersey (WL); Lilly del Caribe, Valeant Pharmaceuticals and Watson Labs. Florida.

• How to Prepared Standard Operating Procedures, World Class Management.

• Word for Windows (Microsoft), Excel, Power Point, The Computer Institute (PR).

REFERENCES: Excellent professional references available upon request.

Contact this candidate