Prfile Angelika Bernard Prcess Engineer (Dipl.-Ing.) Bernard Beratung & Services Dipl.-Ing. Angelika Bernard Reuchlinstrasse 4e D 70178 Stuttgart, Germany Phne: +49 152 0589 5442 E-Mail: a.bernard@bernard-services.cm Internet: www.bernard-services.cm FREELANCER Scpe: Engineering and Quality Assurance in Pharmaceutical Manufacturing Cnsulting services fr the technical design f systems, especially plants fr generatin and distributin f water in pharmaceutical quality Cnsulting services n qualificatin/validatin, executin f qualificatin/validatin Perfrmance and mderatin f risks analysis (FMEA) including dcumentatin Preparatin f User Requirement Specificatins and Functinal Specificatins Preparatin f GMP-cmpliant qualificatin dcuments fr systems Executin and dcumentatin f quality assurance reviews bth n client s site and n supplier s site Supervisin / cntrl f testing which is dne by third parties Evaluatin f quality assurance and qualificatin dcuments prvided by third parties in regard t technical crrectness, cmpleteness, GMP-cnfrmity Prject management in qualificatin/validatin prjects: Crdinatin, cntrl f schedule and prgress, dcumentatin f deviatins as well as tracing f crrected deviatins Preparatin f GMP-cmpliant standard peratin prcedures As at 17.07.2016 Page 1 f 5
Cnsulting and Supprting Services n Quality Management Systems Supprt f Quality Management Systems acc. t ISO 9001, Quality Management Systems fr Medical Devices acc. t ISO 13485 and Energy Management Systems acc. t ISO 50001 Cnsulting and advice in the area f management systems Supprt during implementatin f a management system and ptimizatin f existing management systems. The supprt encmpasses bth cntent and tls used Auditing accrding t ISO 19011 Supprt during preparatin and fllw-up f ISO certificatin audits Acting as external management representative Supprt during implementatin and ptimizatin f integrated management systems, this means e.g. integratin f quality management, envirnmental management and energy management system int a clear and efficiently manageable verall system Preparatin f Technical Dcumentatin Preparatin f technical dcumentatins fr machinery and equipment industry. Preparatin f perating and maintenance instructins in English r German language Integratin f partial dcumentatins, prvided by third parties Crdinatin f translatins dne by third parties Transfrming f dcumentatin int the structure and frmat desired by the final user Management f cmplex dcumentatin prjects including cntrl f schedule and prgress Prject Management and Engineering in Industrial Equipment Industry Design f prcesses Mass and energy balances Piping and instrumentatin diagrams Dimensining f prcesses Preparatin f tender dcuments and rdering specificatins Cmparisn f technical cntent f qutatins Prject management Scheduling and supervisin Crdinatin f sub-suppliers Quality cntrl and assurance Sftwareknwledge Languages Wrd, Excel: excellent PwerPint, Visi, MS Prject, AutCAD, PROfit (prcess mdelling): gd Editrial cntrl system Schema ST4, GFT XLM, SAP / ERP-Sftware: Basic knwledge German and English fluent French basic knwledge As at 17.07.2016 Page 2 f 5
Résumé Freelancer Prjects July 2016 BITCntrl GmbH, Nattenheim Cnsulting regarding the intrductin f an energy management system accrding t ISO 50001 2015-2016 Bsch Packaging Systems AG, CH-Beringen, via Valicare GmbH, Frankfurt (Main) Functinal specificatin, HDS/SDS, qualificatin (IQ, OQ), risk analysis (FMEA), Piping & Instrumentatin Diagram (PID), Standard Operatin Prcedures (SOPs) fr pharmaceutical packaging machines 2015 Industrial Equipment Manufacturer, Baden-Württemberg, Germany Check f P&I diagrams, crdinatin f risk assessment accrding t EU machinery directive and preparatin f perating instructins f a plant 2014 Bayer AG, Wuppertal, via planting GmbH, Karlsruhe Prepared Standard Operatin Prcedures (SOPs) fr an new API prductin, crdinated a team f SOP-authrs, cnducted training, tk part in GMP-risk analyses 2013-2014 Bsch Packaging Systems AG, CH-Beringen, via Valicare GmbH, Frankfurt (Main) Functinal specificatin, HDS/SDS, qualificatin fr pharmaceutical packaging machines 2013 Manufacturing and service cmpany in Saxny, Germany Cnsulting n the quality management system, remdelling f prcesses (Experiences as a permanent emplyee see fllwing page) As at 17.07.2016 Page 3 f 5
Permanent Psitins 2000-2013 Industrial Equipment Manufacturer Stuttgart, Germany 2011-2013 Quality Management-Representative (ISO 9001), internal Auditr 2009-2011 Quality Assurance within an Industrial Equipment Manufacturer, Member f Quality Management Department Tk respnsibility fr quality cntrl fr equipment Supprted the implementatin f a quality management system 2003 2013 Engineering and Qualificatin/Validatin f pharmaceutical manufacturing equipment Prepared qualificatin prtcls DQ, IQ, OQ fr new systems in German and English language Managed qualificatin prjects Perfrmed risk analyses (FMEA) Executed qualificatin testing, factry acceptance testing (FAT) and site acceptance testing (SAT) Wrte standard peratin prcedures (SOPs) Perfrmed a retrspective Qualificatin 2003-2009 Technical Writer (Industrial Equipment Manufacturer) Wrte perating and maintenance instructins in German and English language Managed cmplex dcumentatin prjects 2000 2003 Engineering and Sales f Equipment fr Pharmaceutical Industry Dimensined systems, prepared qutatins and cst calculatins Presented qutatin t client, was invlved in negatins As at 17.07.2016 Page 4 f 5
2000 Operatr f Envirnmental Technlgy / Engineering Cmpany Califrnia, USA Wrked in prjects fr remediatin f cntaminated grundwater and sil 1998-1999 Industrial Equipment Manufacturer Heidelberg, Germany Sales activities Prject executin, engineering 1991-1998 Industrial Equipment Manufacturer Stuttgart, Germany Prepared qutatins fr prcesses fr the remediatin f cntaminated grundwater and sil Tk part in a technlgy transfer prject which lasted 6 mnths Academic Studies 1984-1991 Prcess Engineering at Technical University f Karlsruhe, Germany 2008-2009 Ttal Quality Management at Technical University f Kaiserslautern, Germany Picture credits: www.ft-saenger.de Matthias Matthai As at 17.07.2016 Page 5 f 5