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
COURSES
English courses at IUST
English language skills all levels of PEARSON LONGMAN .
Computer courses like The International Computer Driving License (ICDL) and Visual Basic 2005 (How to Program) at IUST.
German courses at Volkshochschule in Bingen city
Position
Position
GXP Compliance Management
Kompetenzen
Kompetenzen
Top-Skills
TrainerGood Documentation PracticeSystemDokumentationGoal Directed Project ManagementDocument Control CenterComputerized System ValidationIT-ComplianceSAP EHSGood 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.
REFERENCES on request
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
COURSES
English courses at IUST
English language skills all levels of PEARSON LONGMAN .
Computer courses like The International Computer Driving License (ICDL) and Visual Basic 2005 (How to Program) at IUST.
German courses at Volkshochschule in Bingen city
Position
Position
GXP Compliance Management
Kompetenzen
Kompetenzen
Top-Skills
TrainerGood Documentation PracticeSystemDokumentationGoal Directed Project ManagementDocument Control CenterComputerized System ValidationIT-ComplianceSAP EHSGood 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.
REFERENCES on request
Branchen
Branchen
Solids Dosage Form Production
Vertrauen Sie auf Randstad
Im Bereich Freelancing
Im Bereich Arbeitnehmerüberlassung / Personalvermittlung