Quality and Compliance, Requirement Engineer, Business Analyst, Laborleiterung, CSV verfügbar

Quality and Compliance, Requirement Engineer, Business Analyst, Laborleiterung, CSV

verfügbar
Profilbild von Anonymes Profil, Quality and Compliance, Requirement Engineer, Business Analyst, Laborleiterung, CSV
  • 34130 Kassel Freelancer in
  • Abschluss: Approbierte Apothekerin
  • Stunden-/Tagessatz: nicht angegeben
  • Sprachkenntnisse: arabisch (Grundkenntnisse) | deutsch (Muttersprache) | englisch (verhandlungssicher) | persisch (Muttersprache)
  • Letztes Update: 10.07.2019
SCHLAGWORTE
PROFILBILD
Profilbild von Anonymes Profil, Quality and Compliance, Requirement Engineer, Business Analyst, Laborleiterung, CSV
DATEIANLAGEN
Lebenslauf (CV) - Deutsch

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CV - English

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SKILLS
Quality and Qualification Manager
Validation and Qualification of Laboratory Computer Systems for Biotechnology
ISO 13485, ISO 14971, IEC 62304, FDA, GAMP 5, GMP, MHRA, GLP, LIMS, eLN, Spotfire, eDMS
04/19 -Present
- Realization and Implementation of Validation
  strategy for local and global  
  Document IT Management Systems and
  Laboratory Computer Systems 
  Providing strategy and advice to establish a Corporate Framework for 
  Project Governance of Computer System Validation and Equipment
  Qualification during Laboratory Relocation (incl:GAMP5).
- GxP Compliance Analysis and Risk Assessment (FDA,WHO, ICH)
- Creation and Coordination Testing (IQ, OQ, PQ)
- Development and creation of a Traceability Matrix
- Data Integrity (ALCOA, GAMP5, FDA, GMP)

Quality and Qualification Manager
Validation and Qualification of Laboratory Equipment for Biotechnology
ISO 13485, ISO 14971, IEC 62304, FDA, GAMP 5, GMP, MHRA
02/19-Present
-  Laboratory Re-Localization
-  Creation and Realization Critical Assessment for
   Laboratory Equipment (GxP- Criticality Assessment)
- Analysis of the Laboratory Equipment
- Qualification of Laboratory Equipment (FDA, WHO; GMP)
- Requirements Engineering for a new 
  Work and Department Environment (GxP)
- Data Flow Process Analysis
- Visualization and perform a Data Flow Process Map
  for all Business Process and Laboratory Infrastructure (VISO, Miro)
- Laboratory Process Gap Analysis
- Data Integrity for Laboratory (ALCOA, GAMP5, FDA, GMP)

Data Repository Developer
Design of Data Repository for technical and medical data integration and Management
ISO 13485, ISO 14971, IEC 62304, FDA, Conlfuence, JIRA, VISO
9/18 – 3/19
- Design of Data Repository for technical and medical data integration  
  and Management in SaMD within JIRA/ Confluence
- Preparation and Review Medical and Legal Reviews
- Data Repository
- Datafieldanalysis
- Stakeholder Requirements for Data Depot
- Creation of a digital archive (Inc. Directory for storage
  and description of digital objects)
- Linking the data fields of Nutrion Manager with the Data Repository
- Development and creation of concepts for Data Privacy,
  Security and Integrity

Product Owner
ISO 13485, ISO 14971, ISO 9001, ISO 14001, IEC 62304,
FDA, GAMP 5, Usability & IEC 62366, GMP, Conlfuence, JIRA
9/18 – 3/19
- Development of a Software as Medical Devices class IIb
- Product development – und optimization
- Software and Hardware-Testing (IEC 62304, IEC 62366)
- Change Control Documentation
- Development and creation of "Nullserien"
- Requirement Engineering for a
  Software as Medical Devices class IIb
- Analysis and review of medical Guidelines to implement 
  Decision Trees and code it into the software
- Preparation and Review Medical and Legal Reviews
- Development and creation of concepts for Data Privacy,
  Security and Integrity
- Riskassessment (ISO 14971)
- Requirement Engeenier

Quality Assurance Manager
ISO 13485, ISO 14971, ISO 9001, ISO 14001, FDA, GMP, eLN, LIMS, KabiTrack, eDMS, MDD, GAMP5, MHRA, USP, EUAB, SAP/EDV-System
07/18-12/18
- Conceptual improvement, optimization und harmonization
  of global Trainings and eLearning’s
- Lead, participation & execution of Quality Management/
  GMP-projects within the Global Operations
- Conceptual improvement, optimization und harmonization
  of GxP- and quality relevant process procedures for
  pharmaceutical products in quality projects Support of
  Production Units in GMP-compliance related questions
- Elaboration of Quality Management documents
  Preparation & performance of internal &
  external GxP-audits Assistance in
  preparation of inspections by competent authorities
- Analysis and implementation of guidelines
  (GMP, ICH, ISO etc.) and national as well as
  international legal regulations Professional and
  organizational support of the Production Units
- Planning and execution of trainings regarding
  guidelines (GMP, ICH, ISO-certification) and
  national as well as international regulations
- Gap Assessment
- Document Management
- Recall Management
- Ensure that Deviation Investigations and
  Corrective Action/Preventive Action (CAPA)
  plans are implemented to resolve these risks
- Construction, expansion and implementation of a
  Quality Management (DIN ISO 9001 & ISO 13485)
- Data Integrity
Pharmacist
EUAB, USP, ApBtrO, AMG, NRF,DAC, Kosmetik-VO
01/18-07/18
Neue Apotheke, Braunatal (D)
- Ensure the implementation of regulatory Specification
  (AM-HandelsV, GDP-Leitlinie etc.)
- Preparation of intern Inspection and accompaniment
  of Inspection of the supervisory authority
- Creation and implementation of concepts for Work safety
- Quality Management
- Quality Assurance of pharmaceutical Products
- Evaluation of the results of investigated
  Prescription Medicinal Products Concerning the
  Active ingredient concentration, galenic quality (e.g.
  Particle size, appearance, etc.), chemical-physical requirement
  (e.g. ph value, density, stability, etc.)
- Seminars, e.g. on the topic
  «Qualitätssicherung in der Apotheke hergestellter Rezepturen»
- Creation of customer-specific recipes
  according to the regulatory requirements (NRF, DAC, EUAB)

Regional Sales Manager
03/11 – 04/16
- Evaluation and tabular representation of the sales results
- Customer consultation and acquisition
- Creating offers and internal campaign concepts
- Project Management
- Market observation and analysis
- Purchase Transaction

Sales Assistent
06/11 – 04/12
- Customer consultation and acquisition
- Creating offers and campaign concepts
- Market observation and analysis
- Evaluation and tabular representation of the sales results
 
PROJEKTHISTORIE
Tanja Rohark - Rohark Consulting

Anika Kind - Digital Chameleon
ZEITLICHE UND RÄUMLICHE VERFÜGBARKEIT
Reisbereitschaft nach Bedarf.
KONTAKTANFRAGE VERSENDEN

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