Griscar Sandrea Email & Phone Number

United States

College Station, Tx, Us

Bryan/College Station Y Alrededores, Texas, Estados Unidos

Drafting and executing validation protocols and writing validation final reports packages for facilities, utilities, laboratory, EMPQ, manufacturing, automation and quality control equipment in a cGMP environment, as well as, assist with trouble shooting, investigating and managing validation-related issues.

Bryan/College Station Y Alrededores, Texas, Estados Unidos

Main activities and responsibilities: Write C/Q/V documents following established standards and templates.• Perform field/site activities such as: attend witness FATs and SATs, execution of commissioning forms and witnessing of vendor start-up and testing, execution of C/Q/V protocols, walk down, and verification of system drawings.• Compile data and prepare reports for complete C/Q/V activities including protocol data, packages, etc. Blue Mountain Software used.• Assist in deviation, investigation and resolution for problems and issues encountered during field execution activities. • Coordinate with project delivery department or CM for start-up and vendor testing. • C/Q/V of equipment and system, including CVS and automation, supporting pharmaceutical, biotech, and medical device industries.• Assist in the collection and data analysis. Ensures accurate completion of records and reports. This documentation includes, but is not limited to: QMS document revision drafts for calibration procedures, writing new, reviewing & revising existing SOPs, process guides and procedures to meet and maintain quality standards as check about GMP, FDA, 21 CFR part 11 and EHS normative.Type of business or sector: Pharmaceutical, Biotechnology & Medical devices

Cidra

Main activities and responsibilities: Testing Perform: GC, UV-Vis, HPLC, Titrable Acid, Titrable Oil, Conductivity, pH, Chlorine, Fe, Mn to check the water status and mechanical testing; specific gravity and refractometer to the products using SAP R/3. QM● Assist in the collection and data analysis. Ensures accurate completion of records and reports. This documentation includes, but is not limited to: QMS document revision drafts for laboratory quality procedures, writing new, reviewing & revising existing SOPs, process guides and procedures to meet and maintain quality standards as check about GMP, FSMA and EHS normative.● Maintain cleanliness of laboratory and provide preventative maintenance on equipment. May be expected to coordinate equipment inspection, calibration and documentation, May research and draft purchase orders for lab supplies and equipment, Comply with all applicable regulations including PPE requirements in certain areas Type of business or sector: Food Industry FDA Environment.

Gurabo, Pr, Puerto Rico

Main activities and responsibilities:● Metrohm Validation (Calibration, IQ/OQ, Software Managing etc), Mass Calibration, Volume Calibration, Temperature Calibration devices, metrological certification and validation, prepare ISO 17025, write report of weekly activities. Metrological business and certification of devices and certificate material.● Upgrade and Perform a validation activities for 18 SOPs under ASTM standards methods, Perform validation protocols (IQ/OQ) under GMP, FDA & EHS environment.Type of business or sector: Metrology and Calibration Labs (M & C)

Los Puertos De Altagracia

Main activities and responsibilities: ● Meet Quality audits to metrological level, train laboratory personnel for the accomplishment of teamwork quality, establish rules to follow for maintaining the ISO 9001:08 certification and obtaining certification to ISO 17025; 05. ● Management documentation, development and adaptation of ASTM standards, ISO / IEC 17025:2005, OHSAS 18001:2007, ISO 14001:2004, ISO 9001:2008.● Manage the budget of the lab, do the critical selection for buying new equipments.Type of business or sector: Petrochemical IndustryAccomplishments: Upgrade and execute a validation activities for 259 SOPs under ASTM and APHA standards methods, preparation comply with ISO 17025 certification ISO maintain 9001:08, Improving system standard equipment metrological verification and calibration of some level of them. I have reduced 30% response time of the laboratory with the application of new SOPs and using SAP R/3. QM. I won for two consecutive years the award of Polinter EHS, as the worker that better understand and follow all the internal regulations of the company and the petrochemical complex.Analyze and prioritize factors that influence the effectiveness management of multiple projects, for research and development organizations of the petrochemical industries.

Master'S Degree, Managment R&D Projects

Manage multiples projects

Bachelor Degree In Chemistry