freiberufler Manager (Head a.I. - Manufacturing/Operations/LdH, Quality/Corporate/QA/QMS/QC, EHS, QMB, QP/FvP), Advisor&PM (Pharma, BioTech, MedTech, CAPEX/Cross/Multi/Trsf, start-ups, FDA/GMP/GxP, USP/DSP/F&F, OpEx, Lean, MDR/IVDR) auf freelance.de

Manager (Head a.I. - Manufacturing/Operations/LdH, Quality/Corporate/QA/QMS/QC, EHS, QMB, QP/FvP), Advisor&PM (Pharma, BioTech,...

zuletzt online vor 1 Tagen
  • auf Anfrage
  • 8832 Wilen
  • Weltweit
  • de  |  en
  • 22.07.2022

Kurzvorstellung

SME
PM (CAPEX, Cross, etc.)
cGMP/GMP/13485/21 CFRxxx
FDA readiness
Production (USP/DSP, RABS, Isolator, f&f, lyophylization)
QA/QC
EHS
Managementsysteme / IMS / Q-EHS
lean&shop floor (excellence)
-Hyperlink entfernt-

Ich biete

  • CAPEX Projekte (TGA, Invest, Turnarounds)
  • Fill&Finish, Abfüllung, Aseptic/Sterile Production
  • Interim Management
  • Leiter der Herstellung AMG / AMWHV
  • Leiter Pharma Produktion, Quality, QA, QC, RP/QP
  • Leiter Technik, Engineering, Pharma, MedTech
  • Management Systeme (cGMP, GxP, 9001, 14001, 13485)
  • Projektleiter
  • Transfer (Produkte, Technik, Systeme, Methoden)
  • Vacinnes, Biologics, RNS, API, Oncology, OTC, IMP

Zertifikate

Fachtechnisch verantwortliche Person (QP, RP, FvP)
Mai 2012
Senior QA Manager und Deputy FvP / QP
Februar 2012
GMP Auditor
Februar 1994
Fachauditor Chemie
September 1993

Ausbildung

Chemie
(Dr. rer. nat., Dipl.-Chem.)
Jahr: 1992
Ort: Köln

Qualifikationen

Industrieexperte, Senior Consultant, Interim-Manager (Geschäfts-/Betriebsbereiche, Quality/Produktion/Operations/Engineering, mit Ergebnis- und Personal- und Budget-Verantwortung, 160 FTE, 3-Schichtsystem), Projektleiter, Lead Auditor, Senior Trainer in der
- Pharmazeutischen
- Medical Device
- Chemischen
Industrie


Über mich

As Chemist and Industrial Expert I have profound and global experiences in the pharmaceutical, biotechnological, medical device and chemical industry since 1993 (Hoechst/HMR).
My SME competences are Pharma/Biotech/Chemistry Manufacturing&Technology and Quality/QM/QMS, RM, QA/QC in compliance with international regulated requirements (i.a. cGMP/GMP/GDP/GxP, ICH Q10/Q9/Qx, ISO 13485/9001, MDR/IVDR, 21 CFR 210/820, ISO 14971, EHS, REACH).
My competences, expertises as well as my leadership, analyzing, solution, team and integrating network skills are and have been the basic for my responsible tasks and interim positions at Global Player, start-up and medium-sized companies (MAH/CMO/CDMO/OEM) like Roche, Janssen-Cilag, Acino Pharma, BioNTech, Catalent, Novartis, Sandoz, Alcon, EBEWE, Panpharma, RFS, Alstom, Jowat, etc., as:
• Head of Manufacturing/Production (AMG/AMWHV), Fill & Finish, Solida
• Head of Global/Corporate Quality, QA/QC, QMB
• Senior Manager, FvP/QP, Compliance Officer, SME
• Lead Project Manager
• Senior Advisor
• Lead Auditor/Inspection

My key expertises (DACH, Europe, USA, Emergine, Asia, SA):
• products (portfolio, launch, testing, spin offs, bring in market, R&D/innovation): biologic/biosimilar, API, drugs (IMP, SM/LM, liquida, solida, generica, OTC, vacinnes), MDR/IVDR, combinations, chemicals
• site development: construction, turnaround, operating license, organization, QM/EHS systems, TGA, transfer (products, technique, systems)
• project management (CAPEX/invest, readiness, remediation, excellence/top 3, great/multiple, rollouts, cross/matrix structure): PM, PMO/PMI, all-phases (evaluation, designing until closing), team lead, tasks/milestone/timeline/budget/risk tracking, controlling, reporting
• inspections & audits (lead, preparation, simulation, site, corporate, customer): MHRA, Swissmedic, FDA (PAI/post, 483), EMA, ANVISA, MDSAP, SRA, supplier/mock
• quality: strategy, standards, QMS/IMS/SOP, oversight, excellence, QP release, training, QA, deviation/CAPA/change, RM (FMEA), QC (analytic/lean-lab, VR), MiBi, RA, SCM
• manufacturing: strategy, production/operations/packaging management, clinical/dosage/bulk, KVP/CIP, up-/downstream, scale-ups, release/BRR, KPI/right first time, lean production, SFM, deviation/CAPA, RM, EHS
• technique (BAT, aseptic/sterile, A-E): engineering, plants/equipment, facilities/utilities/HVAC/WBI/WFI, CAD, CIP/SIP, pilot/batch/conti plant, fermenter/bio reactor, preparation, RABS, isolator, filtration, lyophilization, crimping, granulation, extraction, coating, packaging, qualifications/validations, CE, high pressure systems and vessels, pipelines, VAwS plants and systems, etc.

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Profilaufrufe
4931
Berufserfahrung
29 Jahre und 3 Monate (seit 05/1993)
Projektleitung
25 Jahre

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