PQMC - Competences

 

Areas of Competence

  • Project Management, Organising and Coordination
  • Pharmaceuticals, Medical Devices & Biotechnologies (QM, RA, CS, Storage & Supply Chain)
  • Lecturer for QM, RA & Validation
  • Food & Pharmaceutical Packaging
  • Ceramic special materials (high-temperature resistant, a.o.)
  • Logistic

Wide Experience in

  • Project Management (e.g. Life-Cycle)

    • Various Technology Consulting Projects
    • Projects at the interfaces Customer - Production - R&D

  • Development of Quality-Management Systems

    • Designing, preparation & implementation of a GMP-compliant Quality-Management System
    • In-house-Trainings, Workshops
    • Documentation basic set-up according to GMP & ISO- guidelines
    • Quality-Management-Manual
    • Standard Operating Procedures, Policies

  • Validation of Computerised Systems - GMP/FDA

    • Development of VMP (Validation Master Plan)
    • Validation of CS according to GAMP, EU-GMP and FDA-Guidelines
    • Life Cycle Documentation
    • Supplier-Qualification
    • Compliance Inspections
    • Development/Review of QS-Documentation

  • Supply Chain Validation

    • Validation of stockrooms (e.g. cold / incubation storage room)
    • Realisation of Validation Steps including qualification testing

  • Regulatory Affairs / Pharmaceutical & Medical Device Submission File

    • Organisation and Coordination of an Establishment Licence Application (ELA)
    • Restructure, translation and connection of Information provided
    • International Project at various production locations

  • Industrial development projects

    • Co-extrusion of PP/PE-films for food packaging
    • Aluminium alloys on foils for deep drawing

  • Food packaging

    • Manufacturing & environmental optimisation, product handling
    • Development & realisation of innovations

  • Ceramic High-temperature-persistent fibres (R & D)

    • Making of ceramic fibres of the system Aluminium oxide / Silicium dioxide
    • Manufacturing/optimisation of precursors (sol-gel-type)
    • Manufacturing & optimisation of fibres (rotary-spin-process)
    • Determination of mechanical properties

Qualität ist das Produkt der Liebe zum Detail!