SQA

Executive Summary:

Over ** years of experience in the pharmaceutical industry with cGMP & FDA Compliance fields, specializing in the area of Computer Systems and Validation for Packaging and Manufacturing. My background includes Information Management Manager for (CSP, Inc), Managing and Supervising external consultants and contract personnel involved in the validation of computerized systems also my experience includes, Medical Device, Pharmaceutical production (Solid & Semi Solids), Sterile and Non Sterile manufacturing and packaging.

SKILLS

• Experience with Active Directory, ERP and MRP systems such as BPCS, CAMS, SAP, DATA Stream, TMS, Active Learner and Qumas.

• Proven knowledge and expertise in the design, configuration, operation, and maintenance of Networks running on Windows NT versions 3.51 and 4.0, 2000, XP and UNIX release 5.0.

• Ability to communicate in written and oral forms in both Spanish and English

• Ability to work independently and to manage multiple tasks.

• Knowledge in PLC: Allen Bradley, Omron, and Koyo.

• Experience: FAT, SAT, IQ, OQ, PQ (SDLC), Commissioning Qualification, Validation Mater Plan, Validation Project Plan, USER Requirements, Functional & Design Specification, Traceability Matrix, Protocol preparation and Request for proposal preparation..

PROFESSIONAL EXPERIENCE:

Bausch & Lomb – Clearwater

SQA/PC/LAN Analyst 2007 – Present

Responsible for: Validation & Verification development and implementation (Performed SQA) on computer systems as a team member throughout the Software Development Life Cycle. Groups supported include Research and Development, Manufacturing Operations, QA/QE, and IM&T. Provide support to users for COTS and other software, with responsive solutions and answers, being able to work through specific problems by testing . Created, updated, trained & executed validation protocols from CAMS 2000 to CAMS Console saving the company over 40k in validation and others activities.

Warner Chilcott - Fajardo, PR

Senior Computer Validation Specialist 2003 – 2007

Responsible for the management and supervision of consultants and contract personnel engaged in the validation of computerized systems, “Request for Proposals” and conducting interviews to contract personnel. Identify plant computerized systems validation needs. Provide leadership and guidance to personnel to assure computerized systems validation was performed in accordance with cGMP's, company policies and procedures, and applicable regulations (FDA, GAMP 4, cGXP, etc.). Manage budget (Data stream), deliverables, and schedule of computerized systems validation projects. Created and implemented with purchasing department a prefer vendor program which saved the company about a 10 % in labor cost also reducing time in selecting vendor for validation activities. Analyzed company Validation Protocols ensuring their strategic fit within goals of organization.

Foster Wheeler USA Corporation - Guaynabo, PR

Computer Validation Engineer 2001 – 2003

Responsible for preparation and revision of Life Cycle Development documents, such as; Factory Acceptance Test (FAT), User Requirement Specifications, Design Specifications, Traceability Matrix, SOP’s, IOQ protocols related to the of Computer Systems Validation Protocols & Validation Reports.

Computer & Software Professionals - San Juan, PR

Information Management Manager 1999 – 2001

Responsible for the successful completion validation and execution for Packaging and Manufacturing Equipment & Training of 30 students in Office 2000, Outlook, Word, Excel, Premises Wiring Management and Infrastructure designer. Created and implemented an incentive program reducing absenteeism by 20% in less than 2 months.

Network & Business Solution - Humacao, PR

Consultant/Technical Supervisor 1996 – 2001

Responsible for: the successful completion of the validation and execution efforts and the proper analysis, design, research and implementation of software and hardware solutions for clients. Master new software applications that will be later implemented in new projects. Installation, configuration, and maintenance of computerized systems for project scheduling, coordination of materials flow (ordering, receiving, and delivery), budget and finances and inventory control. Created and implemented validation protocols saving the company 10k in 3 months.

Mylan Inc. - Caguas PR

Quality Control Technician 1994 – 1998

Responsible for: scheduling and inventory control approval of solid dosage product. Supervise four packaging lines with 10 operators on each line. Responsible for: the development of SOP’s, and cGMP implementation for manufacturing and packaging department.

Schering-Plough Inc - Las Piedras, PR

Warehouse Operator 1993 – 1994

Responsible for: materials movement from incoming/receiving throughout plant. Licensed forklift operator.

McNeil CPC - Las Piedras, PR 1991 – 1993

Packaging/Warehouse/Process Operator

Packing & filling operator for capsule, tablet and packaging lines. Experience with filler machines, capsule filler machines, cottoner machines, capper machines, labeler machines, cartoner machines, sealer machines, and other machines. Process operator responsible for: operations in printing and coating. Experience with coating machines, compression machines, mixing tanks, blenders, and fluid bed dryers (FBD).

Bristol Myers Squibb – Humacao, PR 1984 – 1991

Chemical/Packaging/Manufacturing Operator

Performed as chemical operator for Sterile and non-sterile facilities. Experience with centrifuge, fluid bed dryer (FBD), crystallizing tank product, bubble point check filters, blenders, sterile oven, Filter dryer and cream mixing tanks and machines.

EDUCATION:

May 2005 Masters Business Administration (MBA) Concentration in Management, Universidad Del Turabo, Gurabo, PR

May 2000 Business Administration (BA) Concentration in Computer Science Universidad Del Turabo, Gurabo, PR

May 1996 Computer Repair Courses, Colegio Tecnológico Del Municipio de San Juan, San Juan, PR

Member or affiliation:

• International Society of Professional Engineer (ISPE) Member 259007

• Professional Photographer of PR.(FPPR) # 566

REFERENCES

Provided upon request.

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