Projektleiter in Unternehmensberatung in der Pharma und Pharma IT Industrie für alle CSV, Optimierung, Compliance, Validierung, Roll-outs
Aktualisiert am 31.10.2023
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 31.10.2023
Verfügbar zu: 100%
davon vor Ort: 100%
CSV, Validation
QA
SAP Portfolio and Project Management
Qualitätswesen
SAP
Qualitätssicherung
Quality
English
Mother tongue level, written and spoken
French
Fluent
German
Mother tongue
Hebrew
Mother tongue level
Latin
8 years of education in high school
Russian
Intermediate

Einsatzorte

Deutschland, Österreich, Schweiz
möglich

Projekte

10 Jahre 6 Monate
2013-05 - heute

Project leadership/-coordination

Lead Consultant and Team Leader
Lead Consultant and Team Leader
  • Project leadership/-coordination
  • Validation Team Lead
  • Team Leadership and coordination (Team of 4 consultants)
  • Computer System Validation (CSV) of pharmaceutical IT systems
  • Compliance and validation of pharma production processes
  • Planning, implementation and controlling of pharmaceutical production processes
  • Auditing pharma companies and production processes
  • Consultancy services for Pharmaceutical companies
  • Consultancy services for QA in pharma production processes including GxP compliance, risk management, test management and –documentation
Altran
Consultancy, Germany
10 Monate
2012-08 - 2013-05

Auditing pharma companies and production processes

Consultant
Consultant
  • Auditing pharma companies and production processes
  • Consultancy services for Pharmaceutical companies
  • Consultancy services for QA in pharma production processes including GxP compliance, risk management, test management and -documentation, business process transformation and business process optimisation
  • Consultancy services for SAP solutions
  • Compliance and validation of pharma production processes
  • Compliance and validation of pharma computer systems
  • Planning, implementation and controlling of pharmaceutical production processes
  • Business Development and new customer acquisition

Reason for leaving: break-up of project teams following acquisition of company

IDS Scheer Consultancy
1 Jahr 2 Monate
2011-06 - 2012-07

Setting up and Heading office of LA-SER in Germany

Director of Business Development
Director of Business Development
  • Setting up and Heading office of LA-SER in Germany
  • Responsible for identification of new high level leads and new customer acquisition, using results of own market research and own network
  • Responsible for maintenance of client contact
  • Responsible for all business development activities in Germany, Switzerland, Austria and Israel
  • Main contact point for all external partners, agencies and clients
  • Market research and analysis
  • Responsible for development and establishment of new marketing strategies
  • Responsible for customer proposal development and negotiation

Reason for leaving: closure of foreign offices of the company, including Germany

LA-SER, late-phase clinical study services
3 Jahre
2008-06 - 2011-05

Responsible for the development and implementation of QA standards within the company and external service providers

Head of Business Development and Deputy Head of Quality Assuranc
Head of Business Development and Deputy Head of Quality Assuranc
  • Responsible for the development and implementation of QA standards within the company and external service providers
  • Preparation and execution of internal and external audits, auditing of external service providers (vendor audits)
  • Implementing and monitoring GxP compliance within the company, Change and Risk management, Process validation and Equipment Validation
  • Responsible for GxP training of team and colleagues
  • Responsible for GMO laboratory S1 and S2
  • Head of Business Development: responsible for identification of new leads and new customer acquisition, using results of own market research and own network, responsible for all business development activities of the company
  • Responsible for project proposal development
  • Responsible for all marketing and advertisement activities of the company, including market research
  • Main contact point for all external partners, agencies and clients
  • Responsible for development and establishment of new marketing strategies
  • Responsible for development and establishment of new company strategies and company focus
Output Pharma Services, Germany

Aus- und Weiterbildung

Education

 

11/1996-05/2000       

University of Oxford, U.K. Department of Biochemistry. M.Sc. in Biochemistry.

Thesis: cheP a novel chemotaxis gene

 

09/1991-09/1996         

Bar-Ilan University, Ramat-Gan, Israel, Department of Biology,

Department of Mathematics and Computers. B.Sc. First class


Advanced Trainings and Education

  • Project leadership/-planing trainings
  • Project Ressources Planning
  • GxP trainings
  • GAMP trainings
  • Computer System Validation trainings
  • SAP including PP-PI, SD, MM and QM
  • ARIS Business Process Optimisation Certificate
  • GMO Project leader and Biosafety leader
  • QA/GMP Project leader for the pharmaceutical industry I
  • First Aid responsible in industry
  • Various continuous, internal training courses

Kompetenzen

Top-Skills

CSV, Validation QA SAP Portfolio and Project Management Qualitätswesen SAP Qualitätssicherung Quality

Produkte / Standards / Erfahrungen / Methoden

Computer Skills

  • Routine use of Microsoft Office, Unix systems and CRM Programs (Salesforce)    
  • Good knowledge and understanding of SAP and BPO Programs (e.g. ARIS),

 

Programming Skills

  • Programming experience Pascal, Assembler language, SAS language, Java, C language and C++.

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