SUMMARY OF EXPERIENCE BS Biology/Industrial Microbiology with Minor Degree in Music and Statistics. Thirty (30) years of experienced in the Pharmaceutical/Biotech Industries distributed in QA/QC Microbiology, Industrial Microbiology, Construction, design and Validation, Process, Investigations, Compliance, Manufacturing, Cleaning validation, Documentation, Project Lead/Management, Research and robotic system across EU, US, International and the Caribbean. Validation and design engineering of Potable and Purified Water Systems, utilities such as compressed air, drain systems, HVAC, AHU, HEPA filters, filtration systems, P&ID's, start-up of system and facilities. Manufacturing, Packaging tablets, capsules, cream, powder, aerosol and coating technology implementation. Biotechnology Plant Validation and Qualification of new product and systems/process implementation, lyophylization, harvesting processes. Assigned to new product launches and process, methodology technology transfer from the United States, Australia and England. Process Improvement and Process Validation, integration of process control, design, risk management, lean design principles for operation and laboratory applications as well as implementation and process monitoring. Commissioned to perform special projects with FDA (Food & Drug Administration) to ensure and implement/follow Pharmaceutical/Biotech Industry federal regulations. Hands-on exposure to state-of-the-art processes and equipment within a world class manufacturing operations. Update industry trends and technological advancements. Analytical and research oriented, with a natural direction towards creativity and innovation. Committed to top-quality work and team building structure within the executive professional group totally compromise with quality improvement, creation of new systems start-up plant sites. Methods and microbiology expertise toward the manufacturing process excellence. Technical operations, finished product process validation, project management, investigations, troubleshooting, process optimization and remediation design, Design of Experiment, (DOE), Failure Mode and Effects Analysis, (FMEA) and expertise work mainly on systems, injection/vaccine rooms, sick-building syndrome, surgical rooms and patient affected by airborne contamination during proceedings. Maestro, Delta V and Rockwell experience on alarms configuration, sequence of operation, interlocks qualification through automate systems. Use of Functional Requirements and review to develop qualification protocols and SOP's. Knowledge on Canadian, Japanese, Australia and EU GMP Guidelines. Participates on professional expertise services for court sections. Ten years of experience on regulatory field on comparative analysis reviews and action plans to ensure compliance between global marketing authorizations and plant documents/practices. More than ten years of experience in QA, technical support, and Biotech/Pharma in addition of twenty years of experience in cGMP's, global regulations and report writing experience. Participates in business unit adjudication processes and action plan execution in conjunction with the Quality Unit, and closely interfaces with stakeholders to address and promptly resolve issues. Directing and executing plant Impact Assessment and Remediation commitment plan managing multicultural professional groups at US/EU market. QC/Research laboratory start-up and/or renovation toward lean/six sigma methodologies. Extensive knowledge on OTC products, formulation, and process. Multiple tasks skills, management/lead projects with excellent verbal and writing English/Spanish languages, currently learning Italian. Excellent interpersonal skills focus on goals achievement, fast multi-tasks achiever and public relation affairs. Sales, Project management and Project Planning Business promotion experience. Acrylic arts artist and music performer, scuba diving and tennis. Sandra Acosta Professional Qualifications-Rev. 2018. Address 2717 Seville Blvd. Suite 7103, Clearwater, FL 33764. M- 617.504.7335 Arecibo plant site for PROSCAR * Analyzed and improved packaging line processes and documentation * HAZOP section and automated transfer line systems * Developed quality and process systems in compliance with FDA and pharmaceutical regulations * Evaluated and revised system design with process quality cGMP's and FDA regulations * classified cleaned rooms * Controlled PM's and calibration to avoid non-compliance and maintained good efficiency for equipment and operations * Qualified/Validated the cleaning process and introduced new proposed disinfectant for sanitation adapted to the equipment configuration Lead development and execution and/or revision of validation documentation related to the following cleaning processes Summary of Capabilities EQUIPMENTS EXPERTISE Water Systems CAPA, Investigation and Preventive/Corrective Actions management documentation skill Documentation management, Commissioning, IQ/OQ/PQ's, Validations Plans & Summary Filling/Capper Equipment reports Bioreactors/Cell Culture/Media-Harvest/Purification/Filtration Systems Quality Systems, Track Wise, LIMS HVACC Systems QA/QC and Regulatory Affairs Capabilities Fermentation/lyophylization NDA/Submissions P&ID/FRS/Utilities/Automation/Design/ Controls Medical, Food, Aseptic, & Industrial Microbiology Expertise Direct Compression technology/Glatt Air FDA Inspections/Consent Decrees Antibiotics/Vials/Vaccines Aseptic Areas Labeler/Capper/Dryers/Vial liquid filling/ Blisters Packaging Cleaning Validation, Cleaning Plan Developments Bio-Welder Bio-Sealer Tubing Fusing & Media Fill Directing/Project Management Ultra-Low, Liquid N2 & Chest Freezers P&ID/FRS/Utilities/Automation Bioreactors, Portable Tanks, Skids, Filter Stations, Automate Sequence Excellent interpersonal skills focus on goals achievement, fast multi-tasks achiever Testing CSV-Rockwell, Delta V, Scada Coating/Tablet/Solids Excellent public relationships Walk-in Stability Chambers/Incubators /Autoclave/Freezer/Refrigerator Excellent Scientific data analysis/Excellent interpersonal skills, team work Robotic Systems Excellent verbal and writing English Spanish languages Pharma/Biotech, Fine Chemicals, Hospitals, Food Vaccines and Ocular Medical Devices Clean Rooms Summary Filling/Capper Equipment reports Bioreactors/Cell Culture/Media-Harvest/Purification/Filtration Systems Quality Systems, Track Wise, LIMS HVACC Systems QA/QC and Regulatory Affairs Capabilities Fermentation/lyophylization NDA/Submissions P&ID/FRS/Utilities/Automation/Design/ Controls Medical, Food, Aseptic, & Industrial Microbiology Expertise Direct Compression technology/Glatt Air FDA Inspections/Consent Decrees Antibiotics/Vials/Vaccines Aseptic Areas Labeler/Capper/Dryers/Vial liquid filling/ Blisters Packaging Cleaning Validation, Cleaning Plan Developments Bio-Welder Bio-Sealer Tubing Fusing & Media Fill Directing/Project Management Ultra-Low, Liquid N2 & Chest Freezers P&ID/FRS/Utilities/Automation Bioreactors, Portable Tanks, Skids, Filter Stations, Automate Sequence Excellent interpersonal skills focus on goals achievement, fast multi-tasks achiever Testing CSV-Rockwell, Delta V, Scada Coating/Tablet/Solids Excellent public relationships Walk-in Stability Chambers/Incubators /Autoclave/Freezer/Refrigerator Excellent Scientific data analysis/Excellent interpersonal skills, team work Robotic Systems Excellent verbal and writing English Spanish languages Pharma/Biotech, Fine Chemicals, Hospitals, Food Vaccines and Ocular Medical Devices Clean Rooms Experience Summary (cont.) FROM TO CONSULTING BUSINESS POSITION / COMPANY NAME PROJECT OPERATION & VALUE 1989 1990 Syntex & Co. Humacao, PR Validation Specialist Validation of Robotic System Zymart - $2K 1991 1992 Merck Sharp & Dohme, Caguas PR Quality Control Auditor Auditory and Compliance program. Annual Product Review 1992 1993 Merck Sharp & Dohme, Arecibo, PR Quality Control Microbiologist Startup of Microbiology Laboratory 1992 1993 Merck Sharp & Dohme, West Point, PA Quality Control Microbiologist Product & Method Transfer to Arecibo Plant Site 3B Product & Method Transfer to Arecibo Plant Site, 3B Regulatory Affairs HODDESDON - HEADQUARTERS 1993 1995 Merck Sharp & Dohme, (PR&D) England, UK Certified Quality Control Engineer AND PHARMACEUTICAL RESEARCH AND DEVELOPMENT (PR&D) Experience Summary FROM TO CONSULTING BUSINESS POSITION / COMPANY NAME PROJECT OPERATION & VALUE Sr. Validation Engineer, (SME)/Project Lead Verification and qualification of Walk-In incubator, large freezers viral storage, stability chambers for Cryo
Description
