Training and Documentation Manager for pharmaceutical industry/development. Compliance Manager. Project Manager.
Aktualisiert am 25.07.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.09.2024
Verfügbar zu: 100%
davon vor Ort: 100%
Trainer
Good Documentation Practice
SystemDokumentation
Goal Directed Project Management
Document Control Center
Computerized System Validation
IT-Compliance
SAP EHS
Good Auditing Practice
Arabic
English
German

Einsatzorte

Einsatzorte

Mainz (+50km)
Deutschland
möglich

Projekte

Projekte

4 years
2020-10 - now

Line Management

Training and Documentation Manager
Training and Documentation Manager
  • Supports the line management by keeping process related SOPs up to date.
  • Collaborates with the respective Document Owners (e.g., Authors) of various Divisions and Functions within Boehringer-Ingelheim.
  • Supports the creation of training material for customers (e.g., Authors)
  • Informs Authors on how to proceed when creating revised or new Boehringer-Ingelheim Regulations.
  • Trained as Document Coordinator.
  • Support the Life Cycle Management of controlled documents and collaborate with authors.
  • Foster the system settings of the Document Administration Unit "Operations" as well as the units in Canada, South Africa, Australia and New Zealand and GBS.
  • Implementing new processes and maintaining existing international processes in document management.
  • Create and execute global and local changes in the e-DMS (Veeva Vault and IDEA for CON/GEN) according to business requirements.
  • Lead users worldwide to get required system roles (e.g. signatory roles, ELARPA,etc.).
  • FPL in the global project Unity for GQ division.
Boehringer Ingelheim
9 months
2020-01 - 2020-09

Classification, Export Control and Customs

Analyst
Analyst
  • Classification of items as well as the regulatory compliance of classification activities regarding export control customs tariff and other government agency regulations such as chemical weapons convention
  • Managing transactional activities in the corresponding IT system (SAP GTS) and ensure compliant operations.
  • Supporting the business in terms of customs tariff and export control queries.
Boehringer Ingelheim
2 years 8 months
2017-05 - 2019-12

Solids Production Support

  • Supporting the upgrade of solids manufacturing facilities to cleanroom class D/ISO 8
  • Controlling logbooks documentation in factory Solids in Ingelheim.
  • Familiar with GMP regulations, applicable SOPs and production processes of solids manufacturing.
  • Implementing shared facility (One building multiple products) risk analysis.
  • Avoiding or reducing microbiological contamination in production rooms
  • Preparing for EHS Audit
  • Production control (delivery, performance and productivity)
Boehringer Ingelheim
4 months
2017-01 - 2017-04

Internship in development (Quality and Records Management)

Interne
Interne
  • Learning FDA requirements for medical devices development (QSIT)
Boehringer Ingelheim
1 year 3 months
2015-10 - 2016-12

Integration and German Courses for refugees

  • German language level: C1
1 year
2014-09 - 2015-08

Arranging appointments

Medical rep for vitamins, minerals and food supplements Company.
  • Arranging appointments with doctors, pharmacists and hospital medical teams
  • Building and maintaining positive working relationships with medical staff and supporting administrative staff
Sona nutrition

Aus- und Weiterbildung

Aus- und Weiterbildung

4 years 11 months
2009-10 - 2014-08

Pharmacist

Authorised Pharmacists, International University of Science and Technology, Damascus, Syria
Authorised Pharmacists
International University of Science and Technology, Damascus, Syria

Position

Position

GXP Compliance Management

Kompetenzen

Kompetenzen

Top-Skills

Trainer Good Documentation Practice SystemDokumentation Goal Directed Project Management Document Control Center Computerized System Validation IT-Compliance SAP EHS Good Auditing Practice

Produkte / Standards / Erfahrungen / Methoden

Process Validation
Experte
Word
Excel
SAP

Profile

Enthusiastic, hardworking, ability to learn more, good communication skills and ability to work in a team.

Branchen

Branchen

Solids Dosage Form Production

Einsatzorte

Einsatzorte

Mainz (+50km)
Deutschland
möglich

Projekte

Projekte

4 years
2020-10 - now

Line Management

Training and Documentation Manager
Training and Documentation Manager
  • Supports the line management by keeping process related SOPs up to date.
  • Collaborates with the respective Document Owners (e.g., Authors) of various Divisions and Functions within Boehringer-Ingelheim.
  • Supports the creation of training material for customers (e.g., Authors)
  • Informs Authors on how to proceed when creating revised or new Boehringer-Ingelheim Regulations.
  • Trained as Document Coordinator.
  • Support the Life Cycle Management of controlled documents and collaborate with authors.
  • Foster the system settings of the Document Administration Unit "Operations" as well as the units in Canada, South Africa, Australia and New Zealand and GBS.
  • Implementing new processes and maintaining existing international processes in document management.
  • Create and execute global and local changes in the e-DMS (Veeva Vault and IDEA for CON/GEN) according to business requirements.
  • Lead users worldwide to get required system roles (e.g. signatory roles, ELARPA,etc.).
  • FPL in the global project Unity for GQ division.
Boehringer Ingelheim
9 months
2020-01 - 2020-09

Classification, Export Control and Customs

Analyst
Analyst
  • Classification of items as well as the regulatory compliance of classification activities regarding export control customs tariff and other government agency regulations such as chemical weapons convention
  • Managing transactional activities in the corresponding IT system (SAP GTS) and ensure compliant operations.
  • Supporting the business in terms of customs tariff and export control queries.
Boehringer Ingelheim
2 years 8 months
2017-05 - 2019-12

Solids Production Support

  • Supporting the upgrade of solids manufacturing facilities to cleanroom class D/ISO 8
  • Controlling logbooks documentation in factory Solids in Ingelheim.
  • Familiar with GMP regulations, applicable SOPs and production processes of solids manufacturing.
  • Implementing shared facility (One building multiple products) risk analysis.
  • Avoiding or reducing microbiological contamination in production rooms
  • Preparing for EHS Audit
  • Production control (delivery, performance and productivity)
Boehringer Ingelheim
4 months
2017-01 - 2017-04

Internship in development (Quality and Records Management)

Interne
Interne
  • Learning FDA requirements for medical devices development (QSIT)
Boehringer Ingelheim
1 year 3 months
2015-10 - 2016-12

Integration and German Courses for refugees

  • German language level: C1
1 year
2014-09 - 2015-08

Arranging appointments

Medical rep for vitamins, minerals and food supplements Company.
  • Arranging appointments with doctors, pharmacists and hospital medical teams
  • Building and maintaining positive working relationships with medical staff and supporting administrative staff
Sona nutrition

Aus- und Weiterbildung

Aus- und Weiterbildung

4 years 11 months
2009-10 - 2014-08

Pharmacist

Authorised Pharmacists, International University of Science and Technology, Damascus, Syria
Authorised Pharmacists
International University of Science and Technology, Damascus, Syria

Position

Position

GXP Compliance Management

Kompetenzen

Kompetenzen

Top-Skills

Trainer Good Documentation Practice SystemDokumentation Goal Directed Project Management Document Control Center Computerized System Validation IT-Compliance SAP EHS Good Auditing Practice

Produkte / Standards / Erfahrungen / Methoden

Process Validation
Experte
Word
Excel
SAP

Profile

Enthusiastic, hardworking, ability to learn more, good communication skills and ability to work in a team.

Branchen

Branchen

Solids Dosage Form Production

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