Ricardo Sternberg

Experience

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  Zimet Sternberg Dental Lab

  Jun 1991 - Jul 1999

  Patent correspondence and documents Translations English / Spanish

  Spanish English/ English Spanish translation of technical documents, patents, letters, for filling 4 patent applications at the USPTO through a patent attorney. Barry I Hollander (001 703 8613029, Patent attorney, Arlington VA). At present USPats: 5,444,218; 5,545,875; 5,773,794, Des: 406,343; June 1991- August 1999.

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  Laboratorio Tecnológico del Uruguay

  Mar 2001 - Dec 2001

  • Analista Pasante

    Jul 2001 - Dec 2001

  • Analista Pasante

    Mar 2001 - Jun 2001
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  Universidad de la República

  Mar 2003 - Jul 2005

  Ad Honorem Pharmaceutical Technology Staff teacher

  Position: Ad honorem position Period: 24.03.2003 – 31.07.20052003 - 2005: Regular course of Pharmaceutical technology I y II Academic Program 1980/2000.2004: Practical course Pharmaceutical Industry for TQ degree. CETEP-FQ. Other activities: Particle size determination/globule size determination by Coulter light scattering for APIs and finished product. http://www.polotecnologico.fq.edu.uy/es/

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  Intendencia de Montevideo

  Dec 2003 - Nov 2004

  Academic trainee

  Position: Trainee G1, 30 h/week. Period: 20.11.2003 al 19.11.2004May. 04 – Nov. 04. Laboratory of Chemistry. Drink water physicochemical analysis APHA. Nov. 03 – May. 04. Microbiology laboratory. Marine water sampling along River plate coast, Montevideo Bay. Water microbiological analysis.

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  Caillon & Hamonet

  Jul 2004 - Apr 2008

  R+D Manager

  Period: 16.03.2005 – 16.04.2008. Position: Manager/Analyst of dosage form annual stability program and development program. Tasks: review of current dosage forms stability and newer dosage forms development for filing at national regulatory agency. Formulation, pilot batch production at facility comprising solid dosage forms, semi solid dosage forms, liquid dosage forms and sterile solutions (eye drops and ampoules). Scale up of first commercial batch and personnel training at facility. Development and validation of HPLC stability indicating methods. HPLC training of newer analysts (Q.F. Elena Schiweck). Set up of newer HPLC equipment Waters/Agilent 1100. HPLC Waters Millenium32 v4.0 y Agilent Cessation 1100 v1.0. Brand new OTC/generic products: USP Diclofenac 100 mg delayed release tablet, USP Diclofenac sterile solution, Pear Diclofenac diethyl amine gel, USP Cyproheptadine oral solution, USP Timolol eye drops 0.25 mg/mL + 0.50 mg/mL, Pear Ketoprofen sterile solution 20 + 50 mg/mL, USP Chlorpheniramine oral solution, USP Chlorpheniramine 4 mg and 8 mg tablets. Peru Flunitrazepam injections, USP Ibuprofen 200 mg and 600 mg, USP Sulfasalazine 500 mg (Verefix), Vermicid (PharmaService). Reformulation of Benzydamine spray/oral mouthwash, Ibuprofen 400 mg and 35 mg Orphenadrine citrate. Show less

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  Roemmers

  Apr 2008 - Sept 2010

  Deputy Quality Control Manager - Sterile Product

  Period: 21.04.2008 – 06.09.2010. Position: QC Manager. Report TD, Management. In Charge of: 2 Workers. Total workers: 25 in 2 shifts. Tasks: microbiological analysis and in process physicochemical analysis supervision of sterile dosage forms manufactured either in Plant facility 1 or 2. SOP write and review for QC and QA. Maintenance and internal/external calibration program QC lab equipment: HPLC, UV, TOC, analytical balances, microbiological chambers, autoclaves. etc. Internal production batch record review for major contractors1. OOS investigation, CAPA. Water system daily monitor and validation. Environment check control/monitor for production facility 1, sterile liquid dosage forms (comprising ampoules, flasks and eye drops) and production facility 2 comprising sterile powder dosage forms. Sterile dosage form process validation for plant facility 1 and 2. Cleaning validation program HPLC-DAD/TOC-VSH. In process qualification of ampoule/flasks wash machine (2,3,4,5,10,25,50 mL). External analytical tasks: Imported dosage form HPLC/UV analysis for third parties: Dr. Gray (Argentina), BIOL (Argentina), Nolver (Argentina), Teva Group Uruguay (Teva, Laboratorio Chile, Ivax), Organon (Netherlands), etc. HPLC/UV Analytical method development and validation. Calier SA, Spain. HPLC Analytical support for Laboratorios Haymann SA. 1 www.roemmers.com.uy, www.lablibra.com.uy, www.celsius.com.uy, www.urufarma.com.uy, www.icuvita.com.uy, www.fu.com.uy, www.efa.com.uy, www.servimedic.com.uy, www.lazar.com.uy, www.gador.com.uy. Show less

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  Www.icuvita.com.uy

  Sept 2010 - Jun 2015

  Head Research & Development

  Period: 08.09.2010 – 26.06.2015. Position: Development manager/analyst. Report: PM, TD, QA, Management. Tasks: Search of new product patents, EMA and FDA or national regulatory agencies auditory reports. Galenic and analytical preformulation and formulation. Pilot scale batches manufacture at facility (Tablet dosage forms and sterile dosage forms). Scale up of first commercial batch product and personnel training at facility. HPLC stability indicating method development and validation for API and dosage form. Chiral analysis development in collaboration with Phenologix and ChiralTech. Matrix stability plan execution for climatic zones II and IV for newer product pipeline. New product dossier writing for filing at national regulatory agency. Monthly results review with TD, Management. HPLC-DAD LabSolutions y Shimadzu HPLC Class VP Shimadzu + UV-Probe 2.21.Brand new generic products: Dapoxetine 30/60 mg, Ph.EUR Tiapride 100 mg, USP Fentanyl citrate inj., USP Iopamidol 300 inj., USP Flumazenil inj., USP Methyldopa 250/500 mg, USP Quetiapine 25 mg, USP Tadalafil 5/20 mg, USP Tenofovir 300 mg, WHO Tenofovir 300 mg + Emtricitabine 200 mg, USP Baclofen 10/25 mg, Prasugrel 5/10 mg, Rosuvastatin 10/20 mg. Green coffee dry extract tablets 400 mg in collaboration with Naturex, France. Aliskirene 150 mg. Racecadotril 100 mg. Show less

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  Laboratorio Caillon & Hamonet

  Jul 2015 - Jan 2017

  Production Manager - Solid dosage forms sector / Development Manager

  Period:01.07.2015 – 31.01.2017: Position: Production Manager, solid dosage forms sector.Report: PM, TD, QA, Management. In charge of 1 Supervisor, 2 Coating pan op., 5 Tablet machine op., 3 Granulation op., 2 Capsule filing op., 2 Auxiliary, rest of facility personnel. Total workers: 120 in 2 shifts. Tasks: Management of facility plant personnel and productive resources (high productivity and low productivity tablet press machines, high shear, planetary mixers, granulators, automatic capsule filling machines, fluid bed drier and coating pan). Production time/plan management, weekly/monthly sector production plan for own/client’s products with PM. Batch record documentation review and approval/release through integrated corporative software (GIUS). SOP write and review (Fluid bed operation, cleaning; Capsule machine operation and cleaning). Manufacture methods review/write of solid dosage forms for QA. GMP training of factory workers according to QA. OOS investigation and conclusion, CAPA. Cleaning validation team and support to QA. Simultaneous production lines: 8 processes per shift in solid dosage forms. Supervision of other production facility processes at shift (liquid filling dosage forms stations 2, end product packaging lines 4, blistering lines 2, sterile filling solutions 1, weight control station 1-2). Student Tutorship: Fluid bed validation/Process optimization (3M tablets/month in 20 production batches Dipyrone sodium 500 mg). Final degree annual course Chem. Eng. Valeria Eskenazi. The University of Uruguay, Faculty of Engineering. (598 96303011). Process optimization: own USP Diclofenac 100 mg delayed-release tablet. Reformulation: USP Loratadine 10 mg, USP Domperidone 10 mg for client (www.pellier.com.uy). Show less

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  Laboratorios Caillon & Hamonet

  Feb 2017 - Aug 2017

  Quality Control Supervisor / Development Manager 02.2017 - 08.2017

  Period: 01.07.2015 – 31.10.2018: R+D Manager. Annual stability and new product program execution for filing at the national regulatory agency. Product formulation and galenic development of new drug products (sterile and non-sterile solutions, tablet dosage forms, semi-solid dosage forms) in coordination with the Management and Marketing Dept. HPLC analytical method development and validation analyst direction for current and newer drug products, cleaning validation support. OOS Investigation and conclusion, CAPA. Brand new OTC generic products: USP Sodium Chloride eye drops, PhEUR Oxeladin citrate syrup, USP Acetaminophen 500 mg tablets. Show less

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  Laboratorio Caillon & Hamonet

  Aug 2017 - Feb 2019

  Deputy Quality Control & Manager / Stability and Development Manager 08.2017-02.2019

  Report: QPPV, QA, Management. Managing team of 20 analysts and 120 in production personnel. Management/supervision of 2 analytical sectors: in process control/analytical laboratory. Analytic plan management and Production work management plan for internal and external clients. Meeting output targets on approval of own/client’s raw materials, API, intermediate end product approval. Responsibility for batch release through corporate ERP software. Approval of primary, secondary packing material. Test reports and lab notebooks review. Protocol (SOPs) and document write and review for QC/QA. Providing troubleshooting OOS investigation, CAPA in process or analysis. WFI system and clean room monitor. Permanent training of analytical of QC staff in GMP/GLPs and HPLC+DAD, TOC-L, UV-VIS. Preparing the laboratory for reviews and inspections from clients, the Ministry of Health.February 2017: Set up of new TOC-L Analyzer (Shimadzu) February 2018: Set up of new HPLC-VWD (Shimadzu). Show less

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  Freelance / Contract / Self-Employed

  Mar 2019 - Apr 2020

  Freelance Consultor Pharmaceutical Industry

  09.2019 New inmigrant in Israel. Improved Hebrew language skills at Ulpan Raanana03.2020 Taking active participation in lecturers at Gvahim and Gvahim Network. #Staying at Home and deep E-learning to stay fit during SARS-Covid19 lockdownProcess Validation/ Project Validation Management/ GMP / Equipment QualificationSpreadsheet Validation/ Data Integrity / Cleaning validation

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  SK Pharma

  May 2020 - now

  GMP/GDP Lead Auditor- Quality Control Manager / RA Manager

  Reports to VP Regulatory Affairs, Management. GMP/GDP LEAD AUDITOR for Pharmaceutical Manufacturers and GDP Service providers (EU, USA & Canada, Israel, Asia). A QA Audit team member hosts the IMOH, and external, and internal auditors. QC review and approval for imported dosage forms to Israel from different manufacturers/suppliers under regular import (MAH), 29C, NPP. NPP for Russia & LATAM Markets. QMS management with electronic Dotcompliance® System. Deviations and Quality Complaints handling/investigations for QA. Suppliers qualifications, QTA/QAA/QDA Agreements review and sign-off procedures under cGMP for Israel and European branches. Technology Transfer Agreements for licensed products and CDP report evaluation. Responsible for product launch and renewal of the Reference Standards program (EDQM, USP, etc.). Packaging material QC check for print proof—translations into English and corrections for PILs (German, English, Spanish, Hebrew).CTD Dossier audit evaluation and local documents preparation for submission in Israel of licensed product in EU-CTD Dossier from EU/US/CA/JP/IN MAHs. Israeli MOH Deficiency Letters translations from Hebrew to English. Provide responses to regulatory agencies regarding product information and mediation with manufacturers. Show less