About
nov 2019
Ongoing and recently finished assignments:
- Auditing of new API manufacturer in China according to Eudralex Volume4, Part II for a mid size pharmaceutical company
- QC deputy Manager for 6 months during the recruitment process for the permanent QC Manager, major pharmaceutical company (20+ QC staff)
- Project Manager, Technology Transfer of existing product between two manufacturing sites, major pharmaceutical company
- Project Manager, Technology Transfer of new product from R&D to SC major pharmaceutical company
- QA responsible for Technology Transfer, new product from R&D to SC major pharmaceutical company
- QA/IT Responsible, different companies
- Project Manager, process optimization, major food manufacturing company
- CSV Validation Management
Quality
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
Compliance
Audit services
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
Security
Information Security related services
Records and Information Management
- Routines for Regulatory and Business Critical information
Data Integrity
- Data integrity is a prerequisite for the regulated healthcare industry
GDPR
- Establishment of GDPR framework
- GAP analysis / Improvement of GDPR processes
Project Management
Senior Project Managers
IT system introduction / roll out, e.g.
- SAP R/3
- Movex M3
- EBR
- LIMS
- HR & Payroll
Serialization and aggregation projects
Product Lifecycle Management (PLM)
- Initial conception
- Design control (R&D)
- Industrialization
- Product care
- Product decommissioning
