Scope: Engineering and Quality Assurance in Pharmaceutical Manufacturing

Transcription

1 Prfile Angelika Bernard Prcess Engineer (Dipl.-Ing.) Bernard Beratung & Services Dipl.-Ing. Angelika Bernard Reuchlinstrasse 4e D Stuttgart, Germany Phne: a.bernard@bernard-services.cm Internet: 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 Page 1 f 5

2 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 and Energy Management Systems acc. t ISO 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 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 Page 2 f 5

3 Résumé Freelancer Prjects July 2016 BITCntrl GmbH, Nattenheim Cnsulting regarding the intrductin f an energy management system accrding t ISO 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 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 Page 3 f 5

4 Permanent Psitins Industrial Equipment Manufacturer Stuttgart, Germany Quality Management-Representative (ISO 9001), internal Auditr 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 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 Technical Writer (Industrial Equipment Manufacturer) Wrte perating and maintenance instructins in German and English language Managed cmplex dcumentatin prjects 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 Page 4 f 5

5 2000 Operatr f Envirnmental Technlgy / Engineering Cmpany Califrnia, USA Wrked in prjects fr remediatin f cntaminated grundwater and sil Industrial Equipment Manufacturer Heidelberg, Germany Sales activities Prject executin, engineering 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 Prcess Engineering at Technical University f Karlsruhe, Germany Ttal Quality Management at Technical University f Kaiserslautern, Germany Picture credits: Matthias Matthai As at Page 5 f 5