Chemist / Validation Specialist

Miguel Alsina

************@*******.***

Cel 787-***-****

SUMMARY OF QUALIFICATION

Experience in Pharmaceutical, Biotechnology, Vitamins and Naturals Product with strong background in Analytical Laboratory and Instrument/Equipment Validation in GMP environmental. Fast-learner and team worker oriented. Able to handle multiple tasks with minimum supervision. Experience using variety of laboratory equipment such as HPLC, UV/VIS, FTIR, NIR, Dissolution, Karl Fisher, Atomic Absorption and TOC. Strong experiences in method validation, assay, content uniformity, dissolution, impurity/degradants and other analytical test. Strong background in full computer life cycle documentation (CSV) where I developed User/Functional Specification, Validation Plan, Design Specification, Traceability Matrix, Installation/ Operational/ Performance Qualification, Final Reports, System Regulatory and Risk Assessment, 21 CFR Part 11 Assessment and SOP’s for Laboratory and Process Analytical Technology (PAT) Instruments

EXPERIENCE

Dec/2008–Sep/2009 Vitarich Laboratories Naples, Fl

Chemist

 Managed the Quality Control Laboratory with three Laboratory Technicians as direct reports ensuring that the work schedule was performed efficiently and effectively to meet on time demands. Responsibilities included scheduling and assigning workload to include testing all incoming raw materials and compounds. Functioned as a working supervisor to perform Assay Testing, Heavy Metals, Loss On Drying, Residue on Ignition, NIR and identification testing of all raw materials, in process and finished products. Assisted with testing and equipment trouble-shooting. Responsible for final approval and release of the raw materials and in process samples.

Sep/2008–Nov/2008 Haemacure Sarasota, Fl

Validation Specialist (Consultant Position)

 Instrumental in the start-up of the Haemacure facility in Sarasota, Fl developing SOP’s and IQ/OQ/PQ for Laboratory and Manufacturing Process Equipment

Dec/2006–Mar/2008 Wyeth Pharmaceuticals Guayama, PR

Senior Validation Specialist (Consultant Position)

 Participated in the implementation of Process Analytical Technology (PAT) and Quality by Design (QbD) at Wyeth Pharmaceuticals Guayama

 Prepared Computer System Regulatory and Risk Assessment, 21 CFR Part 11 Assessment, User/Functional Specification (UFR), Design Specification (DS), Traceability Matrix, SOP’s, Deviation Report and IOPQ for PAT Instruments

 Monitored PAT manufacturing process validation “Compression, Blending and Roller Compactor” using Brimrose NIR 5030, Insitec Particle Size Analyzer Model T and Model X, and Bruker MPA

 Obtained and responded to QA review, provided guidance on quality issues that affect the integrity of the data of the system, performed as part of the validation but not limited to different tests such as: Critical screens with valid/invalid data entries, critical alarms and error messages, confirmation of appropriated power failure responses, challenging system security testing multi-users access, testing communications reliability between the computer and interfaced system, testing backup and recovery procedures. Recommended corrective actions to provide security of the PC’s connected to the PAT instruments.

Jan/2006–Dec/2006 Bristol Myers Squibb Humacao, PR

Validation Specialist (Consultant Position)

 Developed laboratory analytical method and laboratory in-process method validation protocols following ICH guidelines. Prepared cleaning validation, laboratory analytical mMethods and laboratory in-process methods reports. Reviewed method transfer and laboratory cleaning validation binders for approval.

Oct/2004–Jan/2006 Glaxo SmithKline Cidra, PR

Validation Specialist (Consultant Position)

 Managed projects validation activities including but not limited to coordination and execution of field activities, development validation protocols including Validation Plan, User Requirement Specification, Functional/Design Specification, Traceability Matrix, Validation Summary Report, Deviation and Investigation Report for Laboratory Equipment

Oct/2002–Mar/2004 Schering Plough Las Piedras, PR

Method Transfer Analyst

 Performed various laboratory analytical methods as HPLC, Atomic Absorption, FTIR, Dissolution, Assay and Degradation Products, Content Uniformity, Blend Uniformity, Residues Determination “Cleaning” and Uniformity of Dosage. Reviewed and audited laboratory analytical data.

Oct/2001–Aug/2002 Janssen Ortho Gurabo, PR

Raw Material Analyst (Temp. Position)

 Executed analytical test following USP and EP, i.e. Assay Fatty Acid, Assay Polyols, Viscosity, Arsenic, Lead, Vinylpyrrolidinone, ROI, LOD, FTIR, UV, Iron, TOC, Purified Water (Nitrates, Heavy Metal, Conductivity), Karl Fisher, TLC, pH and Heavy Metal.

EQUIPMENT EXPERIENCE

 HPLC – Alliance, Shimadzu, Agilent, Perkin Elmer

 NIR – Brimrose 5030, Buchi NIRFLEX N-500

 Atomic Absorbtion – Perkin Elmer

 FTIR – Perkin Elmer, Nicolet

 TOC – Anatel, Sievers, Shimadzu

EDUCATION

1996–2001 University of Puerto Rico, Cayey

 Bachelor Degree in Chemistry

TRAINING

Millennium 32, Empower, GMP, GLP, Word, Power Point, Excel, Visio and Project

REFERENCES

Available upon request

Contact this candidate