PQMC - Projects

 

Projects


  • Quality Management Systems Remediation

    • Position: Quality Manager GLP, Projectmanagement GMP
    • Duration: 8 months
    • Operations:
      • Laboratory Document-, Structure & Process-Analysis
      • Design & guidance to implementation of improvements
      • Improvement of "Data Integrity"
      • Training of staff
      • Projectmanagement & GMP-Expert for Setup of GMP-Laboratory
      • ... etc.
    • Standards:
      • GDP, GLP & GMP
  • Interim Quality Manager

    • Position: Regional Quality Manager
    • Duration: 18 months
    • Operations:
      • Adjustment & Setup of QM-Structures
      • Makeup & Adjustment of needed documents (e.g. SOPs, Change Control, CAPA, Record Management, ...)
      • Support for Head of Corporate Quality Managament and Regulatory Affairs
      • Building compliance to national licence-application-documentation requirements
      • Quality representative to local authorities, inspections & Customer Audits
      • Training of staff
      • Accountable for Quality KPIs
      • ... etc.
    • Standards:
      • EU-GDP-2013 (Good Distribution Practice)
      • AMBO 2009 (Austrian regulation)
      • GMP

  • Auditor

    • Position: nonGxP/GxP-Auditor
    • exp. Duration: 6-24 months
    • Operations:
      • Review of Efficacy-Testing-Reports for compliance with Good Documentation Practices
    • Standards:
      • GDP (Good Documentation Practice)
      • GLP, GCP, GMP

  • Transport Validation

    • Position: Project Management, Validation-Consultant
    • exp. Duration: 9 Month
    • Operations:
      • Project Management
      • Validation Strategy
      • Lead of process- & riskanalysis
      • Training of employees (Inspection-preparation)
      • Introduction to project & hand-over to new Quality Manager
      • ... etc.
    • Standards:
      • EU-GDP-2013 (Good Distribution Practice)
      • AMBO 2009
      • GMP

  • Raw-Data Audit

    • Position: GDP/GCP-Auditor
    • Duration: 1 week
    • Operations:
      • Review of Lab-Reports for compliance with Good Documentation Practices and check of correct entry to CRO-Data-Base
    • Standards:
      • GCP & GDP (Good Documentation Practice)

  • CAPA Manager API

    • Position: QM-Consultant
    • Duration: 14 months
    • Operations:
      • Management & Completion of CAPAs
      • SOP-Reviews
      • Risk Analysis
    • Guidelines:
      • ICH Q7
      • ICH Q9
      • ICH Q10

  • Transfer-Validation of computerised Systems

    • Position: Project Management, Validation-Consultant
    • Duration: 11 months
    • Operations:
      • Project-Management of an inter-facility validation team
      • Validation Strategy (transfer)
      • Validation Programme (transfer)
      • User Requirement Specifications
      • Functional Specifications
      • Risk Analysis
      • Validation Report
      • Review and Creation of Documents/Documentation (GAMP5)

  • Harmonisation of QM-System according to international GMP-Standards

    • Position: Project Management QM- / GxP- and RA-Consultant
    • Duration: 11 months
    • Operations:
      • Adjustment of QM-Structures
      • Makeup of needed documents
      • Support for Head of Corporate Quality Managament and Regulatory Affairs
      • Support in building compliance to international licence-application-documentation requirements
    • Guidelines:
      • ISO 13485
      • FDA QSR 21 CFR 820
      • ISO 13485 CMDR (Canada) & MDC (Taiwan)

  • Restructuring/Implementing QM-System

    • Position: Project Management QM- / GxP- and RA-Consultant
    • Duration: 16 months
    • Operations:
      • Finding & implementation of structure-basics for Quality Management
      • Setup of necessary organisational arrangements
      • Re-working of the QM-Documentation
      • Temporary Group-Quality-Manager (app. 6 months)
      • ISO-/FDA- & ANVISA-audit-preparation & -guiding
      • Supporting & updating of licence-application-documentation
      • Training of employees
    • Guidelines:
      • ISO 13485
      • FDA QSR 21 CFR 820
      • ISO 13485 CMDR (Canada) & MDC (Taiwan)
      • ANVISA RDC 59 (Brasil)
      • MHLW Ministerial Ordinance 169 / PAL (Japan)

  • GMP-Facility-Design

    • Position: Facility Design Consulting
    • Duration: 2 days
    • Operations:
      • Check of design of new production facility
      • Designing of process- & material-flows
      • Input on shopfloor-design (e.g. P&ID
      • Review of documents/documentation

  • GMP-Product-Audit

    • Position: External Auditor
    • Duration: 1 week
    • Operations:
      • Pre-Audit Questionnaire
      • GMP-Auditing of API-development & -production as 3rd-Party-Auditor
      • Audit-Reporting

  • CSV in Medical Device Production

    • Position: Project Manager & GxP- (Expert) Consultant
    • Duration: 15 Month
    • Operations:
      • Validation Designing (retrospective and prospective)
      • User Requirement Specifications (URS)
      • Functional Specifications (FS)
      • Risk Analysis & Traceability Matrix
      • Design Specifications (DS)
      • Validation Programme (VP)
      • Support in Source Code Review
      • Installation Qualification (IQ)
      • Operational Qualification (OQ)
      • Validation Report
      • Review and writing of content

  • Validation of eCRF-Systems

    • Position: Project Manager & GxP- (Expert) Consultant
    • Duration: 16 Weeks
    • Operations: same as in "CSV in Medical Device Production"
      • see above

  • US-Submission-File (FDA BLA Establishment part, Vaccine)

    • Position: Projektkoordinator, GxP- (Expert) Consultant & File-Writer
    • Duration: 10 Weeks
    • Operations:
      • Organisation of respective information (various production locations)
      • Linking of information
      • Cross-referencing (e.g. drawings, tables)
      • Review and writing of content
      • Restructuring
      • File preparation
      • IT-Validation consulting

  • IT-System Monitoring

    • Position: Project Manager, GxP- (Expert) & IT-Consultant
    • Duration: 5 months
    • Operations:
      • Documentation of Purchasing
      • Functional Specifications (FS)
      • Risk Analysis
      • Traceability Matrix
      • Design Specifications (DS)
      • Validation Programme (VP)
      • System-Installation- & Customising Guides
      • Design Qualification (DQ)
      • Installation Qualification (IQ)
      • Operational Qualification (OQ)
      • Technology Benchmarking
      • Validation Report

  • US-Submission-File (FDA Establishment Licence Application, Vaccine)

    • Position: Project Coordinator, GxP- (Expert) Consultant & File-Writer
    • Duration: 14 Weeks
    • Operations:
      • Organisation of respective information (various production locations)
      • Translations (German - English)
      • Linking of information
      • Cross-referencing (e.g. drawings, tables)
      • Reviewing of content
      • Restructuring
      • File preparation

  • Storage Area Network

    • Position: GxP- (Expert) & IT-Consultant
    • Duration: 6 months
    • Operations:
      • Documentation of Purchasing
      • Functional Specifications (FS)
      • Risk Analysis
      • Design Specifications (DS)
      • Validation Programme (VP)
      • System-Installation- & Customising Guides
      • Design Qualification (DQ)
      • Installation Qualification (IQ)
      • Supplier Auditing
      • Operational Qualification (OQ)
      • Technology Benchmarking
      • Validation Report

  • Basic GMP IT-Infrastructure

    • Position: GxP- (Expert) & IT-Consultant
    • Duration: 9 months
    • Operations:
      • Design & creation of requirement analysis
      • Workshops/Interviews
      • Hotline-Support
      • User requirement analysis (URS)
      • Documentation of Purchasing
      • Functional Specifications (FS)
      • Process Analysis
      • System-Installation- & Customising Guides
      • Design Qualification (DQ)
      • Installation Qualification (IQ)
      • Supplier Auditing
      • Technology Benchmarking
    • Technology:
      • MS Win2000 Advanced Server & Management Tools
      • MS Terminal Service Client
      • Compaq/HP Server Management Tools

  • QM-System Implementation

    • Position: Project Management QM- / GxP- & IT-Consultant
    • Duration: 8 months
    • Operations:
      • Providing a basis for Quality Management
      • Generating of necessary organisational arrangements
      • Providing of a QM-Manual
      • Writing of the appropriate SOPs (general & organisational operations)
      • Training of employees
    • Guidelines:
      • ISO 9000:2000
      • API Q7a
      • EU & FDA GMP

  • Cold-Storage (retrospective)

    • Position: GxP-Expert
    • Duration: 3 months
    • Operations:
      • Assessment of "Status Quo"
      • Designing/Proposals regarding rebuilding/additions according to GxP-Requirements
      • Design and Guidance during Qualification

  • Laboratory Information Management System (LIMS)

    • Position: Project Management, GxP-Consultant
    • Duration: 7 months
    • Operations:
      • User requirement analysis (URS)
      • Functional Specifications (FS)
      • Process Analysis
      • Instructions for System-Installation- & Customising
      • Design Qualification (DQ)
      • Installation Qualification (IQ)
      • Operational Qualification (OQ)
      • Technology Benchmarking
      • Validation Report

  • Service Level Agreements

    • Position: Organisation-Consultant
    • Duration: 3 Weeks
    • Operations:
      • Creation of SLAs for nonGMP-purposes

  • Requirement Specifications

    • Position: GxP- & IT-Consultant
    • Duration: 3 Weeks
    • Operations:
      • Analysis of Basic Requirements on IT-Systems
      • Requirement Documentation on Compatibility of new IT-Systems

  • Revalidation ERP-System

    • Position: GxP-Consultant
    • Duration: 2 Weeks
    • Operations:
      • Operational Qualification (OQ)

  • Validation Basics for CS

    • Position: QM- / GxP-Consultant (Project Manager)
    • Duration: 1 Week
    • Operations:
      • Writing of the appropriate SOPs on Validation of CS
    • Guidelines:
      • OECD GLP-Consensus Document
      • FDA Title 21 CFR Part 11 (ERES)
      • ICH Guideline for Good Clinical Practice
      • GAMP4

  • Audit preparation & QM-/Validation-Lecturer

    • Position: Lecturer
    • Duration: by the day
    • Operations:
      • Audit preparation of IT-Department and Software Supplier
      • Lecturer for Quality Management and GxP-Validation

  • CAPA (Corrective and Preventive Action) "Pilot project"

    • Position: Department representative, Member of project team
    • Duration: 6 months
    • Operations:
      • Data acquisition of inventory turnover & storage duration
      • Data analysis
      • Workshops/Meetings
      • Conceptual design of CAPAs in Cent. Warehouse/Dispatch
      • Consulting in conceptual design of CAPAs in other departments

  • New incubation storage (prospective)

    • Position: Project Manager
    • Duration: 5 months
    • Operations:
      • Coordination & surveillance of validation activities
      • Communication and coordination of internal and external suppliers
      • Coordination & surveillance of rebuildings

  • Validation of Computerized Systems (CS)

    • Position: QM- / GxP-Consultant (Project Manager)
    • Duration: 2 months
    • Operations:
      • Set up of a Validation Master Plan for validation of CS
      • Writing of the appropriate SOPs
    • Guidlines:
      • FDA Title 21 CFR Part 11 (ERES)
      • GAMP4

  • Computer-System Security Check

    • Position: IT-Consultant (Project Manager)
    • Duration: 2 days
    • Operations:
      • Guidance of analysis & removal of bugs in quality- & security-relevant Systems

  • Laboratory Information Management System (LIMS)

    • Position: GxP-Consultant
    • Duration: 2 weeks
    • Operations:
      • User requirement analysis (URS)

  • Co-Extrusion-coated Al-Container for food packaging

    • Position: Project team member
    • Duration: 20 months
    • Operations:
      • Coordination of all internal and external R&D-Activities
      • Summarising raw-data
      • In charge of pilot productions
      • Guidance & Coordination of pilot productions at customer sites

  • Reduction of Aluminium of Pet-food-containers

    • Position: Project Manager
    • Duration: 20 months
    • Operations:
      • Coordination of all internal and external R&D-Activities
      • Summarising raw-data
      • In charge of pilot productions
      • Guidance & Coordination of pilot productions at customer sites

  • Food-Pouches (steriliseable)

    • Position: Project Manager
    • Duration: 9 Month
    • Operations:
      • Coordination of all internal and external R&D-Activities
      • Summarising raw-data
      • In charge of pilot productions

Qualit├Ąt ist das Produkt der Liebe zum Detail!