Interim Manager (Head Production, Technik, Quality, QA, Analytics, QP), PM Großprojekte & Advisor (Pharma, MD, Chemie)

freiberufler Interim Manager (Head Production, Technik, Quality, QA, Analytics, QP), PM Großprojekte & Advisor (Pharma, MD, Chemie) auf freelance.de
Europa
de  |  en
120‐200€/Stunde
7084 Brienz/Brinzauls
18.10.2020

Kurzvorstellung

Strategy & Organization
Lead PM (CAPEX, Multiple, Cross)
cGMP/GMP/13485/21 CFR 210/211/820
FDA readiness/remediation
Aseptic Production (USP/DSP)
QA / QM
lean & shop floor
technique (RABS, Isolator, transfer, etc.)
Best in Class / Excellence

Ich biete

Management, Unternehmen, Strategie
  • Interim Management

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

Zertifikate

Leiter der Herstellung AMG/ANWHV / Leiter pharmazeutische Produktion Fill % Finish (aseptisch, steril, terminal)
Juli 2019

ISO 13485
Februar 2017

Stell. Leiter der Herstellung AMWHV (Solida)
August 2016

Referent FDA Quality Oversight (ECA Master Kongress, Wien)
Juni 2016

Head of Global Quality / Corporate Quality
Juli 2014

Senior QA Manager Pharmatechnik / Deputy FvP/QP
Juli 2013

Fachtechnisch verantwortliche Person (QP, RP, FvP)
Mai 2012

Senior QA Manager und Deputy FvP / QP
Februar 2012

Zertifizierung Auditleiter ISO 9001
Februar 1998

Akkreditierung TGA Auditor 14001 Chemie
November 1997

GMP Auditor
Februar 1994

Fachauditor Chemie
September 1993

Sachkundiger TÜV Druckbehälter und Rohrleitungen
März 1990

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
Europa
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Profilaufrufe
2646
Berufserfahrung
27 Jahre und 5 Monate (seit 05/1993)
Projektleitung
25 Jahre

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