Bruun & Maté AB is a management consulting and technology services company located in the Oresund area in Southern Sweden.
New employee at Bruun & Maté!
We welcome Jörgen Lidén as a new Senior Consultant at Bruun & Maté! Jörgen has an extensive experience within the pharmaceutical and medical device industry, managing computer system validations and infrastructure qualifications through meticulous project execution and exceptional team leadership.
Main areas of expertise: Computer System Validation, Infrastructure Qualification, Quality Management Systems, SOP development, Data Integrity, Project Management - certified PRINCE 2 practitioner.
Q2S, Quality as a Service -
Long term Collaboration (Assignment)
Provide the following services:
- Hire of QP (Qualified Person)
- Hire of Responsible Person (Distribution of pharmaceuticals)
- Hire of department QA / QC Managers
- Hire of project QA Managers
- Hire of Quality Engineer (e.g. Complaint investigations, Risk Management, Change Management)
- Analysis and Reporting – PQR, APR etc.
Provide management and responsibility of a QMS:
- Develop and Maintain a compliant QMS
EU GMP, GDP, Medical Devices
- Suppliers, Laboratories, internal QA/QC departments, CMO/CRO
- distributors, repackers, transport companies of pharmaceuticals
- EU GMP, EU GDP, MDD/MDR, ISO 13485, 21CFR820, 21CFR210
- IT Processes, In-house IT departments, Software Development Processes
- Due-diligence of QMS organizations and processes
QMS related services
GAP analyses, Establishment, reconstruction, extension of QMS systems
- EU GMP, GDP, MDD/MDR, ISO13485, 21CFR820, 21CFR210 or other regulatory requirements
Validation and qualification services
- Manufacturing, laboratories, administrative systems, HVAC etc.
Serialization and aggregation
Services related to clean rooms / sterile environment
Information Security related services
Records and Information Management
- Routines for Regulatory and Business Critical information
- Data integrity is a prerequisite for the regulated healthcare industry
- Establishment of GDPR framework
- GAP analysis / Improvement of GDPR processes
Senior Project Managers
IT system introduction / roll out, e.g.
- SAP R/3
- Movex M3
- HR & Payroll
Serialization and aggregation projects
Product Lifecycle Management (PLM)
- Initial conception
- Design control (R&D)
- Product care
- Product decommissioning