people4project GmbH
Lörenskogstr. 3
85748 Garching b. München
Mo-Fr 9.oo - 17.oo Uhr
+49 (89) 55 29 39 -40
Kontakt
people4project GmbH
Lörenskogstr. 3
85748 Garching b. München
Mo-Fr 9.oo - 17.oo Uhr
+49 (89) 55 29 39 -40
Kontaktdaten anfordern
Freelancerprofil: -0130856
Interims-, Transfer- and Project Management, Due Diligence, Projektleiter
- IT-Erfahrung seit:
- 2015
- Position:
- IT Beratung / Consulting
Management
Program Management
Projektleitung / Organisation / Koordination
Qualitätssicherung / Test
| Projekte im Werdegang |
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| 06/2015 - | NLP Master
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| 01/2013 - | SAP-QM - Qualitätsmanagement, Pharmazie, Sicherheitstechnik Integration Management Global Quality Operations and Merger Integration - Production Leader and Project Team Leader for Launch Execution and set up of production areas of sterile drug products (drug product transfer, internal/ external launch with successful validations, RABS, liquids, vials, prefilled syringes, lyophilized vials, small molecules and biologics); Due Diligence and strategy preparation and business cases for launch site decisions; no audit findings - Transfer of drug products / APIs to Third Party Manufacturers and their qualification within the Global Quality Department; Due Diligence; Build up a RABS-production as Project Manager and Head of Production; Implementation and training of a Quality Management (QM) System for Medical Devices, and subsequent passed Notified Body Audit (no findings); Project facilitation and strategic evaluation; QA/ QM development within sterile pharmaceuticals; facilitating teamwork as external driver; turnaround of projects using QM-tools and Project Management; Lead Auditor; (between 4 -19 months) - FDA-, EMA, ICH-Guidelines (mainly sterile drugs and validation); ISO 13485 - Projects at GSK, Janssen - Cilag (Schaffhausen, Geel and Beerse), Novartis AG (Stein, Basel and Ringaskiddy), Sandoz (Kundl / Schaftenau Takeda and with external partners: Siegfried AG, Hovione, Rohner, BASF, Patheon Production Leader, Project Team Leader |
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| 05/2011 - 12/2012 | Good Manufacturing Practice Aseptic production of cytostatics and non-cytostatics (vials and ampoules), responsible for 62 employees Production, optical control, packaging, storage of medical products; validation and qualification of processes and equipment according to national and international law (GMP); process optimization, planning, budget and training FDA-Audit (7days, only 2 minor observations, May 2012) Operational turnaround and reorganisation of the production Development of a portfolio strategy Output-increase of 40% with identical machinery and 12% more employees Process improvements with waste reduction up to 50% (combined with application of statistical project evaluation) Strong reduction of employee turnover using feedback talks and team building measurements Implementation of a substitution scheme and maintenance planning Working close with customers Head of Sterile Production |
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| 01/2011 - | Henley Alumni
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| 04/2009 - 12/2010 | SAP-QM - Qualitätsmanagement, Käser, Pharmazie, Good Manufacturing Practice, ISO 9001 MILEI GmbH (a subsidiary of Morinaga Milk Industries, Japan) and ALDA GmbH (a cottage cheese factory of Allgäuland-Käsereien GmbH) Leutkirch, Germany Research, development, and quality management of active pharmaceutical ingredients (API), excipients, highly refined milk and whey based products, and cheese; QM-Systems (GMP, IFS, DIN-ISO 9001, Eco-food, kosher, halal); food law; responsible for 23 employees Development of a business strategy, working on turnaround Initiation of a strategic and portfolio realignment Focus R&D on customer oriented products Application of statistical process evaluation and tighten portfolio Implementation of a substitution scheme Sanitization of the water system Head of Quality Assurance and QM, Head |
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| 12/2006 - | Biologie Biological safety of medical devices, TÜV Süd, München |
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| 07/2006 - | Auditor according to DIN-ISO 13485; Vorest AG and LGA 07/2006 Product Quality Review, PCS
Auditor
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| 07/2005 - | Qualification and validation in QC, LGL, Oberschleissheim
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| 04/2002 - | Pharmazie, Marketing Informationsbeauftragte im pharmazeutischen Unternehmen' Heidelberg; Translation: Responsible person for release of advertising material (function according to German Medical Product Law) Der Informationsbeauftragte |
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| 12/2000 - 03/2009 | Pharmazie, Six Sigma, Good Manufacturing Practice Project Leader, Quality Assurance Manager, Regulatory Affairs Manager Quality assurance for sterile medical products (dental syringes), their active pharmaceutical ingredients and medical devices, packaging materials, cosmetics, and food; assurance of process stability and product quality of parenteralia; writing quality reviews; analytical and stability testing; formulation development; release control of pharmaceuticals and secondary batch release; organizational projects, Six Sigma projects; lead auditor for GMP and medical devices (ISO 13485); regulatory affairs management of medical products and medical devices; release of medical information; specialist for materials of animal origin Project Leader, Quality Assurance Manager |
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| 10/1999 - 09/2000 | Analytical Project Leader, LAT GmbH Dr. Tittel, Gräfelfing, Germany
Analytical development for regulatory drug approval
Project Leader
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| 09/1998 - 09/1999 | Pharmazie Project Leader in Formulation Development, SWISS CAPS, Bad Aibling and Kirchberg, Switzerland Customized formulation and analytical development of pharmaceuticals for clinical and analytical trial batches and for registration purposes Project Leader |
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| 01/1997 - | Chemie, Toxikologie GDCh (Society of German Chemists), Groups: Food Chemistry, Water Chemistry, Ecotoxicology Quality- and PM-Groups of Xing und Linkedin |
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| Branche |
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| Gesundheitswesen Hochschulen und Forschungseinrichtungen | |||||||||||||||||||||||||||||||||||||||
| Kenntnisse |
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| Ausbildung & Zertifikate |
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| Sprachen |
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| deutsch | (++++) | ||||||||||||||||||||||||||||||||||||||
| englisch | (++++) | ||||||||||||||||||||||||||||||||||||||
| französisch | (++++) | ||||||||||||||||||||||||||||||||||||||
| italienisch | (+) | ||||||||||||||||||||||||||||||||||||||
| spanisch | (++++) | ||||||||||||||||||||||||||||||||||||||
| Sonstiges |
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people4project GmbH
Lörenskogstr. 3
85748 Garching b. München
Tel: +49 (89) 55 29 39 -40
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