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.
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.
