With 24 years of experience in international pharmaceutical companies, he excels in quality control and assurance, particularly in vaccine production, and has a strong background in GMP consulting and training
He has extensive expertise in deviation management, CAPA, change management, and documentation, including SOP creation, batch record review and implementation of electronic batch records
As a leader, he has managed teams of up to 10 employees, organized and conducted training sessions, and served as a lecturer in pharmaceutical quality assurance, demonstrating his ability to present complex content clearly
He has previously worked with us on several projects, consistently receiving outstanding feedback from our clients
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Overview
- Availability
- Asap, 5 days/week,on-site & remote
- Qualification
- Certified Industrial Master´s in Pharmacy, Certified Validation Officer, Quality Management Specialist QMF, GMP Compliance Manager
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- QA Expert, GMP Consulting, Deviation Management, CAPA, SOP Creation, Batch Record Review, Electronic Batch Records, Tech Transfer, Documentation, Team Leadership, Training, Project Management, Pharmaceutical
Key-Facts
Extract from previous activities
Pharmaceutical Industry
QA Manager / Batch Record Specialist
Support in change control
Process validations
Batch Record Review
Pharmaceutical Industry
QA Manager
Creation and revision of SOPs and PQRs
Pharmaceutical Industry
Document Expert / Electronic Batch Records Specialist
Implementation/design of electronic batch records
Document creation
Pharmaceutical Industry
QA Compliance Manager / CAPA Manager
Review, evaluation, and approval of deviations/OOS
Creation of CAPA measures
Comparison of regulations and documentation of change requirements
Document review
Pharmaceutical Industry
QA Support
Investigation and evaluation of deviations, creation of deviation reports, document review
Pharmaceutical Industry
Document Specialist
Creation of new SOPs for production
Consolidation of existing SOPs and templates
Creation of deviation reports and qualification documents
Pharmaceutical Industry
Process Expert
Process optimization and deviation management
Investigation and evaluation of process deviations
CAPA creation
Pharmaceutical Industry
QA Deviation Specialist
Investigation and evaluation of deviations
Creation of CAPA measures
Pharmaceutical Industry
Lecturer/Trainer for QA and GMP Topics
Pharmaceutical quality assurance
GMP training
Pharmaceutical Industry
Various Roles within the QA Area
Cross-functional activities including handling deviations, investigations, CAPAs, and changes
Creation, revision, and review of GMP-compliant documents (e.g., SOPs, instructions, PQR)
Support/participation in audits/inspections (RP, FDA, etc.). Review of batch records and other documents