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Resume of QDF
Consultant

EXPERTISE AND SERVICES

Utilities, Facilities Qualification, Validation, Expert Consultant
Expertise in equipment /systems, computer system validation (CSV), utilities and facilities qualification /validations, manufacturing and packaging in solids, semi-solids and bulk industries.

Validation and compliance experience includes coordination, leadership and project management, qualification (IOP/Q).

This consultant has experience in coordinating the validation and installation activities with other consultants, engineering firms and construction contractors

PRINCIPAL INDUSTRIES SERVED
Pharmaceutical, Medical, Utilities, Food, Manufacturing, Computer

EDUCATION
M.S., Water Treatment Sciences Candidate, Inter American University of Puerto Rico, San German Campus
B.S., Industrial Microbiology, University of Puerto Rico, Mayaguez Campus

PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.

Providing expertise in industrial microbiology, water treatment, utilities and facilities qualification, computer system validation, manufacturing and packaging, and related expertise to a wide variety of clients.

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Case Studies

Industrial Microbiologist, USP Water Purification System Qualification, microbiology and environmental monitoring products manufacturer

Development of Validation Plan and Schedule. Development and execution of IQ/OQ/PQ documentation for one new Reverse Osmosis /UV water purification system unit. Managed validation efforts. Was in charge of project schedule. Developed and executed Engineering Study to determine optimal operational parameters. Coordinated deliverables with construction contractors.

Documentation Auditor, Ivax Pharmaceuticals, Cidra PR

Audited Batch Records, including Manufacturing Instructions, packaging orders, Laboratory Results, and ancillary data, in accordance to cGMP’s, GDP and company policies, procedures and standards.

Bioburden Assessment Analyst, Becton Dickinson and Co., Las Piedras PR

Bioburden Assessment to Medical Device’s manufacturing facilities to determine possible source of microbial contamination. Prepared Action Plan to lower Bioburden counts.

Industrial Microbiologist, Validation Master Plan, Biovail Laboratories, Dorado PR

SOP revision and edition for Quality Systems (Process Validation, Computer Validation, Cleaning Validation). Qualification/Validation [deliverables] audit. Risk Assessment (FMEA) development for qualification priority of manufacturing equipment, utilities and facilities. Site Validation Master Plan assistance. Product Transfer: Tiazac and Diltiazem Process Transfer from the Carolina’s facilities to Dorado following FDA’s SUPAC Guidelines for Immediate Release Solid Oral Dosage forms. Coordinated efforts alongside with plant personnel, and develop Process Validation deliverable for Technology Transfer of oral dosage products (Mixing/Unit Dosing/Packaging). Execution of the Process Validation/PQ protocols. (Weighting, Granulation, Spheronization, Sieving, Fluid Bed Drying, Oven Drying, Blending, Encapsulation, Capsules Packaging, Stability studies).

Industrial Microbiologist, USP Water Purification System Qualification, Watson Laboratories, Copiague, NY

Development and execution of IQ/OQ/PQ documentation for one (1) new USFILTER Reverse Osmosis/UV water purification system unit. Managed validation efforts.

Compressed Air Use Points Quality Sampling Analyst, Bristol Myers Squibb, Manatí PR

Quality sampling on compressed air use points (dew point, hydrocarbon, and particulate). Managed validation efforts.

Netilmicin Plant Equipment Qualification Commissioning, Schering Plough, Manatí PR

Commissioning report development and execution for Active Pharmaceutical Ingredient (API) Equipment (Reactor Tank, Mixer Tank, Chiller and Filtering/Distillation Column).

Industrial Microbiologist, Biologic® Computer System Validation, Lilly del Caribe, Carolina PR

Initial development of Computer System Validation (CSV) documentation for one (1) Biolog® rapid microbiological identification unit. Managed validation efforts.

Laboratory Equipment Qualification; Environmental Chamber Qualification, Pfizer Global Manufacturing, Arecibo PR

Development of System Development Life Cycle (SDLC) and Computer System Validation (CSV) documentation for laboratory equipment (Dissolution Bath, pH Meter, Tritino, FTIR, Glassware Washer, Analytical Balance). Development and execution of IQ/OQ/PQ documentation for the qualification of two (2) new ES2000 Environmental Chambers. Development of operational SOP’s for two (2) new ES2000 Environmental Chambers. Managed validation efforts.

ADDITIONAL EXPERIENCE

Compressed Air System Qualification; Pressure Differential Monitoring System Qualification, Bristol Myers Squibb, Manatí PR
Development and execution of IQ/OQ documentation for the qualification of one (1) new ATLAS COPCO Compressed Air Unit. Development and execution of IQ/OQ documentation for the re-qualification of two (2) old ATLAS COPCO Compressed Air Units. Quality sampling on compressed air use points (dew point, hydrocarbon, and particulate). Development of operational SOP’s for an ATLAS COPCO Compressor and Sequencer. Execution of computer system validation (CSV) protocol for a new pressure differential monitoring unit. Managed validation efforts.

Waste Water Treatment System Commissioning, Pharmacia Global Supply, Arecibo PR
Commissioning protocol development and execution for a new Water Filtering System, a Water Softener System, and a Compressed Air System. Quality sampling on compressed air points. Managed validation efforts.

Compressed Air System Qualification, Ortho Biologics LLC, Manatí PR
Development and execution of System Development Lifecycle documentation for the qualification of a new Compressed Air System. Quality sampling on compressed air points. Manage validation efforts.

Manufacturing Facility Qualification; Water Chiller Qualification, Guidant, Dorado PR
Execution of qualification protocol for a new chiller unit. Development and Execution of qualification protocol for a new manufacturing facility. Quality sampling on compressed air points. Managed validation efforts.

Multi-Dose Equipment Qualification, Ortho McNeill Pharma, Manatí PR
Development of Computer System Validation (CSV) documentation for one new Multi-dosing laboratory equipment. Coordinated validation activities.

Ultraviolet Spectrophotometer Equipment Re-qualification, Janssen LLC, Gurabo PR
Execution of Computer System Validation (CSV) for two (2) Ultraviolet Spectrophotometer laboratory units. Coordinated validation activities.

Quality Assurance Supervisor, Perdue Farms Inc., Accomack, Virginia
In charge of daily quality reports, product specification documentation, employee training programs etc. Supervision and coaching of up to twenty-five employees, providing liaison between management and associates. Monitor critical control points (HACCP) in processing and handling procedures to ensure reliable and high quality product prior shipping. Reported directly to QA General Manager.

Waste Water Treatment Plant Operator, SaniPlant Inc., Joyuda, Cabo Rojo PR
Management of a private, small capacity, "active sludge" waste water treatment system. In charge of Supervisors and the Maintenance Department. Daily testing to ensure proper balance of microbiological & chemical agents. Proficient in wastewater management technology.

PROFESSIONAL AFFILIATIONS
ASQ Certified Six Sigma Green Belt (CSSGB)
Six Sigma Black Belt in training

Please note that this is an abbreviated CV. A fully detailed unabridged CV is available under special circumstances.

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Kevin Kennedy & Associates, Inc.
Rapid Response Engineering® Solutions
3905 Vincennes Road, Suite 320
Indianapolis, Indiana 46268
(317) 536-7000 voice
(317) 536-7220 fax

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