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Resume of BHI
Consultant
EXPERTISE AND SERVICES
Qualification, Validation, FDA Regulations Expert ConsultantExpertise in regulatory, compliance, commissioning, and validation (RCCV) issues of a facility, inspection activities, FDA regulations, cGMP, CAPA, equipment /systems, computer system validation (CSV), utilities and facilities qualification /validations, manufacturing and packaging in solids, semi-solids and bulk industries.
This consultant's validation and compliance experience includes leadership and project management, qualification (IOP/Q), coordination with other consultants, engineering firms and construction contractors
PRINCIPAL INDUSTRIES SERVED
Pharmaceutical, Biotechnology, Manufacturing, Computer
EDUCATION
B.S., Microbiology, University of Puerto Rico, Humacao Campus
Industrial Biotechnology Sciences (107 credits completed); UPR, Mayagüez Campus
PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.
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Providing expertise in industrial microbiology, pharmaceutical and biotechnology consulting, utilities and facilities qualification /validation, manufacturing and packaging, FDA regulations, and related expertise to a wide variety of clients.
Speak to this experienced, world-class expert now.
- Call (317) 735-4883
- E-mail bhi@rapid-response-consulting.com
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Antibiotic PPU-MIR Team, pharmaceutical and biotechnology firm
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Completed, tracked, and trended manufacturing discrepancies and resulting commitments within their respective assignment. Initiated an MIR and coordinated the actions required for its resolution. Recommended corrective and preventive actions to prevent/eliminate recurrent discrepancies and led its implementation at the affected area. Measured CAPA effectiveness. Identified opportunity areas to improve processes, equipment and job performance at the areas. Defined, in conjunction with area leadership team, and implemented operational excellence tools and projects that could facilitate the improvement of those areas. Worked closely with Operations and Quality Assurance, ensuring that all investigations are performed according to corporate and site guidelines. Ensured timely completion of manufacturing discrepancy commitments. This included writing, revising, or coordinating the efforts for change controls, standard operating procedures, testing specifications, batch documentation, training documentation, validation/technical documentation, work orders, purchase orders, and others. Maintained regulatory compliance by initiating MIRs as needed and ensuring that personnel document all manufacturing discrepancies and resulting changes, whether process, equipment, or procedural, as per regulatory and company policies. Gathered data and did evaluation to identify root cause and possible trends. Developed CAPA's to avoid event recurrence. Commitment generation to ensure that preventive and corrective actions were performed.
Support Services for Validation Department for the Coating Project, Team Leader of Scales, Tanks, Drum Lifters, Control Systems and Utilities, CCCP Project, GlaxoSmithKline, Cidra, P.R.
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Was responsible for the coordination of validation specialist activities, schedule and to provide status reports of projects activities. Supervised the Technical Writers that are responsible of SOP formatting and translation. Developed SOP training packages including power point presentation and training evaluation for train the trainers. Addressed customer complaints by following a problem solving methodology to comply with the Regulatory Agencies. Provided services related to quality and regulatory compliance issues. Developed and reviewed critical deviation investigations. Evaluated Equipment and Process Changes as a member of the Change Control team. Reviewed CAPAs and followed up the pending items to be approved by Quality.
Validation Consultant, Biotechnology Plant, Lilly del Caribe, Inc, Carolina, P.R.
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Collected and analyzed historical data to identify trends and root cause of manufacturing deviations. Recommended corrective and preventive actions to prevent and/or eliminate discrepancies and leads its implementation. Was responsible for revision the protocols and critical deviations / investigations for the HUMALOG Project, including measuring CAPAs effectiveness (Biotechnology Process). Supervised the Purification Team coordinating validation and execution activities to comply with the schedule and project budget. Area improvement in accordance to Quality issues.
Validation Consultant, Optical Lenses Manufacturer, Cooper Vision Puerto Rico, Inc., Juana Díaz, P.R.
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Was responsible for analytical laboratory instruments and methodology validation including the execution of deviations and investigations reports, identification of root cause and recommends effective CAPA's. Supervised microbiologists during executing activities and problem solving during procedure executing. Created and evaluated graphics from test data. Validation of existing chemical and microbiology methods (Bioburden, Air Sampling, Sterilization). Development of microbiological evaluation for the manufacturing area.
Consultant, Solid Dosage Form Manufacturer, Pfizer Pharmaceuticals Limited, Inc., Vega Baja, P.R.
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Was responsible for protocol development, field execution and reporting of the following systems: Utilities - HVAC Systems Qualification, Facilities - Packaging Line 11 Qualification.
Baxter Healthcare Corporation, Carolina, PR
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Supervised employees during the first shift of production. Verified that FDA requirements are met by complying with the procedures and specifications. Coordinated manufacturing activities to comply with production schedule.
Microbiology Laboratory, Schering Plough, Manatí PR
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Executed the respective microbiology tests of the Afrin products in order to accomplish with the SOP's based on the GMPs regulations.
ADDITIONAL EXPERIENCE
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Seminars and Training
Investigations (CAPA's)
21 CFR Parts 210, 211(cGMP's)
21 CFR Part 820 (Quality System Regulation)
21 CFR Part 11 (Electronic Records & Signatures)
System Development Life Cycle (SDLC)
Good Automated Manufacturing Procedures (GAMP)
Good Documentation Practices (GDP)
Bilingual communication skills (Spanish and English)
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