alexandra precup

validation engineer ii

About

BS in Chemistry with 18+ years of professional experience almost ten of those in the pharmaceutical/medical devices industry working as a Lab Analyst, QA/QC Specialist, Chemist and Validation Consultant. Involved with product and method transfer activities. Experience in CQV activities, laboratory and manufacturing equipment validations, decommissioning, non-conformance investigations and internal audits . Experience in change control, quality management systems and operational excellence. Previous experience in CAPA Plan, consent decree remediation plans and plant start-up processes, site-utilities validation, packaging systems validation and process validation. Also Laboratory experience in raw material analysis, incoming inspections, and different laboratory techniques such as HPLC, GC, FTIR, MS, potentiometric titrations, etc. Also have strong background in Real Estate Sales, Complex Sales, strategic planning, scheduling, leadership roles, lobbying, management, budgeting, team supervision.

Country

united states

City

duluth

Industry

chemicals

Skill

analytical chemistry, corrective and preventive action, analytical method validation, pharmaceutical industry, research, lean six sigma, root cause analysis, strategic planning, microsoft office, microsoft excel, oratoria, supervisory skills, fda gmp, root cause problem solving, gc fid, ftir, good laboratory practice, analytical chemist, high performance liquid chromatography, u.s. pharmacopeia, european pharmacopeia, laboratory equipment, laboratory equipment validation, leadership, consent decree, bulk material handling, raw materials laboratory experience, instructor, analisis de datos, educacion, control de calidad, capacidad de analisis, calidad de proveedores, comunicacion escrita, directivas gamp, poe, control de cambios

Experience

office manager and associate broker

re/max realty city/precup real estate

2013-3 - 2018-10 · 5 yrs 8 mos

president

caguas board of realtors®

2017-1 - 2017-12 · 1 yr

Member of the BOD for Puerto Rico Association of REALTORS(PRAR) since 2016 to 2018. Former Chairman for New Member Committee for CBR, Former Chairman for RPAC Committee for PRAR on 2017 & 2018. Former PRAR-PAC founding member and Treasurer from 2016 & 2018, PR State Representative at RPAC Member Involvement Committee at National Association of REALTORS on 2017-2018

chemist iii

legacy pharmaceuticals puerto rico, llc

2008-8 - 2009-8 · 1 yr 1 mo

Development and generation of protocols and final reports for laboratory method validation and laboratory method transfer activities. Working in the creation and implementation of new laboratory systems in order to comply with Good Laboratory Practices and FDA Regulations. Creation, revision and execution IQ/OQ/PQ/MPQ for laboratory equipment. Revision of analytical data. Coordinate laboratory activities, in absence of laboratory supervision.

validation scientist

glaxo smith kline phrmcuticals

2007-12 - 2008-8 · 9 mos

Worked with remediation plan for consent decree activities. Designing Experiments for methods in order to improve efficiency of the actual method of analysis for manufacturing areas. Development and writing protocols and final reports for validation activities. Development of complex technical protocols, reports and related documentation. Trained personnel for the execution of protocols projects. Perform commissioning, qualification, and validation testing on manufacturing process equipment and instruments; author protocols, initiate controlled documentation. Generation of documents such as master plans, design qualification, equipment, facility and utility commissioning and development and development of final reports. Lead CQV projects and teams. CQV project initiation, inception, design, development, implementation, management, follow up, and maintenance.

qa and qc senior lab analyst

eli lilly and company

2005-11 - 2007-12 · 2 yrs 2 mos

laboratory specialist

schering pharmaceuticals

2002-8 - 2005-9 · 3 yrs 2 mos

Support on consent decree activities. Laboratory analysis on raw materials, solid dosage, and bulk. Wet chemistry, nitrogen content, water content, TLC, HPLC, GC, UV-VIS, FTIR Spectometry, ph, polarimetry analysis. Conductivity, TOC, Solvent analysis. USP/NF, EP, BP.

laboratory analyst

bristol-myers squibb

2001-6 - 2002-8 · 1 yr 3 mos

validation specialist

validation & engineering group, inc.

2018-10 - Present · 7 yrs 11 mos

Responsible for coordinating and executing validation projects and master plan. Generate, execute and review master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Support the development of the Process Validation Master Plan. Analysis the results of testing and determine the acceptability of results against pre-determined criteria. Coordinate with other departments or outside contractors/vendors to complete validation tasks. Mentoring less experienced Specialists. Manage projects and preparation of status reports. Supported the development and implementation of the Process Validation program. Developed documentation associated with Process Validation program using the FDA Guidance. Provided hands on support and technical project management in the development, execution, and maintenance of the Process Validation program.

director of operations and owner

academia entorno musical

2007-2 - 2017-9 · 10 yrs 8 mos

Team supervision, scheduling, budgeting. Inventory management. Creation of marketing and sales plans. Equipment purchasing. Startegic plannning. Events coordinations.