Quality Assurance Project, Biotech (Therapeutic)
- Kiel, Germany, Sterile Filling & Visual Inspection, EU & US requirements
• Establishing a Particle Contamination Control Strategy
• Risk Assessments for Particulate Contamination Pathways of Filling Lines
• Implementing Trending of Particulate Contamination Levels
• Standardize Particle Incident Risk Assessment & Escalation Schemes
• Establishing a new Document Structure in VI
Quality Assurance Project, USP & DSP, Biotech (mAb)
- Wuppertal, Germany, Quality Assurance, EU & US requirements
• Interim Head QA Operations (USP & DSP, 6 FTE)
• Qualification Compliance (Utilities, USP & DSP Process Equipment, CSV, QC, Clean Rooms)
• QA Operations & Engineering Support, Setup of GXP compliant Processes and Documentation
Manufacturing Project, Comp. & Sterile Filling, Biotech (Vaccines)
- Leverkusen, Germany, Technical Operations, EU & US requirements
• Interim Head Technical Operations (Comp. & Filling, 80 FTE)
• Production Planning (Material Mgt, Batch Docu, Comp. & Filling & VI/Packaging)
Quality Support Project, USP & DSP, Biotech (mAb, Vaccines)
- Wuppertal, Germany, Quality Unit, EU & US requirements
• Risk Assessment Cross Contamination
• QA Support Qualification & Validation Compliance
Quality Support Project, Comp. & Sterile Filling, Biotech (Vaccines)
- Leverkusen, Germany, Quality Unit, EU & US requirements
• QA Support Qualification Validation Compliance
• Project Support Process & Documentation
• Audit/Inspection Preparation (QRAs, CCS, APS-report, etc.)
C & Q Support Project, Sterile Compounding Facility (Small Molecules)
- Hettlingen, Swizerland, Qualification & Validation Unit, EU & US requirements
• Coordination, Planning and Performing of C & Q Tasks
• Qual & Val Documentation, Generation & Review
Quality and MFG Project, Comp. & Sterile Filling (Small Molecules)
- Wasserburg, Germany, Quality Unit & Manufacturing Depart., EU & US requirements
• QA Operations Support, Batch Record Reviews & GMP-Assessments & Closure of Deviations
• QA Systems Support, Assessment Qualification (Fill & Finishing, Packaging) & Deviation Management
• Manufacturing Support, Update of Master Batch Records, Closure of Deviations & CAPAs
Capacity Expansion Project, Comp & Sterile Filling, Biotech (Therapeut.)
- Leverkusen, Germany, Quality Assurance Biotech Department, EU & US requirements
• QA Project Support, C&Q (Compounding plant, Auxiliary Equipment, Small Equipment)
• Validation-, Qualification- & GMP-Compliance
• Cleaning Validation Support
Manufacturing Project, Logistic & Distribution (Small Molecules)
- Linz, Austria, Documentation, EU & US requirements
• Generation of Transport Validation Protocol and Report
Manufacturing Project, Comp & Sterile Filling (Small Molecules)
- Singen, Germany, Compounding & Sterile Filling, EU & US requirements
• Interim Head Sterile Production, Line Function (Comp. and Filling)
• Full Budget and Personnel Responsibility (4.2 Mio € & 150 FTE)
Virus Safety Project, Cell Culture Plant, Biotech (Therapeut.)
- Basel, Switzerland, Cell Culture Manufacturing, EU & US requirements
• Evaluation and Assessment of Virus Safety Concept of the Cell Culture Plant
• Audit Support
Manufacturing Support Project, Comp & Sterile Filling (Small Molecules)
- Singen, Germany, Compounding and Sterile Filling, EU & US requirements
• GXP Support, SOP Review & Updates, FDA Prep. Training
• Summaries and Presentations for Audit
• FDA Preparation Team Lead
Clean Area Concept in API Production, Support Project (API Mfg.)
- Ingelheim, Germany, API Manufacturing, EU & US requirements
• Generation of Interim Transition Report
Process Validation Support Project (Therapeutic Proteins)
- Marburg, Germany, Fractionation & Downstream Processing, EU & US requirements
• Generation of Process Validation, Stability and Impurity Profiling Reports
Laboratory Relocation Project (Diagostica)
- Munich, Germany, Clinical & Development Laboratory, EU & US requirements
• Generation of Project Validation Master Plan
• Relocation Impact Risk Assessment
Virus Safety Project (Therapeutic Proteins)
- Schaftenau, Austria, Cell Culture Manufacturing, EU & US requirements
• Document and Summarize the Virus Safety Concept of the Cell Culture Plant for
Authority Presentation & Submission
Engineering Department Interim Management Project (Vaccines)
- Düsseldorf, Germany, Biotech Manufacturing, EU & US requirements
• Management of the PM, CM and CAL team (Clean Utilities, MFG and QC Assets)
• Support of Cross-functional Project Teams
• Implementation of a computerized Maintenance Management System
Process Validation Support Project (Therapeutic Proteins)
- Marburg, Germany, Fractionation & Downstream Processing, EU & US requirements
• Generation of Process Validation and Impurity Profiling Reports
Conditioning Concept for Closed Equipment in API Production, Support Project (API Mfg.)
- Ingelheim, Germany, API Manufacturing, EU & US requirements
• Report/Summary of a Concept for Conditioning of Closed Equipment in API Production
Clean Area Concept in API Production, Support Project (API Mfg.)
- Ingelheim, Germany, API Manufacturing, EU & US requirements
• Generation of an Evaluation and Change Over Master Plan
Particulate Contamination in APIs, Support Project (API Mfg.)
- Ingelheim, Germany, API Manufacturing, EU & US requirements
• Documentation of Concept in regard to Particulate Contamination in APIs
• Generation of Final Report for FMEA Risk Assessment for Particulate Contamination in APIs
Process & Cleaning Validation Support Project
- Linz, Austria, Technical Service Department, EU & US requirements
• Generation of Submission Summaries for Process Validation & Cleaning Validation Projects
Risk Assessment Project
- Schaftenau, Austria, Cell Culture Clinical Manufacturing, EU & US requirements
• Generation of Risk Assessment in regard to Raw Material
(specification, regulatory requirements, testing, utilization & supply chain)
Process & Cleaning Validation Support Project
- Marburg, Germany, Fractionation & Downstream Processing, EU & US requirements
• Generation of Final Reports for Process Validation Projects & Cleaning Validation Projects
• Generation of Life Cycle Assessment Reports & Impurity Profile Investigation Reports
Production Support Project
- Düsseldorf, Germany, Biotech Manufacturing, EU & US requirements
• CCA Performance Qualification (Documentation, Management & Report)
QC & QA Support Project
- Schaftenau, Austria, Cell Culture Clinical Manufacturing, EU & US requirements
• Generation of Stabilty Report
Process Validation Project
- Schaftenau, Austria, Cell Culture Clinical Manufacturing, EU & US requirements
• Generation of Process Virus Validation & Scale Down Validation Report
Production Department Interim Management Project
- Düsseldorf, Germany, Biotech Manufacturing, EU & US requirements
• Interim Management of the manufacturing operations team (Upstream & Downstream)
• Support of Cross-functional Project Teams (QC, QA, PLE, SCM)
• Enforce measures to gain full GMP-Compliance within the manufacturing operation teams
Risk Assessment Project
- Schaftenau, Austria, Cell Culture Clinical Manufacturing, EU & US requirements
• Generation of Risk Assessment in regard to Cross Contamination
Process Validation Project
- Unterach am Attersee, Austria, Technical Operations Department, EU & US requirements
• Process Validation, Concepts & Requirements, Support
• Sterile Filter Validation, Concept & Documentation Support
• Generation & Reviews of Process Validation Protocols & Reports
• Execution & Coordination of Process Validation Projects
Quality Assurance Support Project
- Vienna, Austria, Quality Assurance Department, EU & US requirements
• Quality Assurance Support, Extension of Manufacturing Site:
Assessment of Change Controls and Deviations
• Validation Compliance Support, Quality Systems Support
• Validation Master Plan & Validation Project Plan
• Validation & Qualification Reviews
Business Process Optimization Project
- Frankfurt, Germany, Quality Control Department
• Business Process Optimization, Quality Control Labs, Evaluation, Analysis, Action Plan, Follow up
• Management Process Optimization, Quality Control Department; Management, Evaluation, Analysis
• Project Management, Process Optimization Quality Control Laboratories
cGMP - FDA, EU Compliance Project
- Frankfurt, Germany, QC, Downstream & Filling Processes, EU & US requirements
• FDA-Compliance Upgrade in Quality Control Unit
• Project Management Support, Sub-Project Manager QC
• Review and Assessment of Quality Systems(Change Control & Deviation Management & OOS),
Documentation, Processes and Procedures
• Validation / Verification Quality System Definition, Implementation, Documentation and
Performance Support
• Qualification Analytical Equipment, Documentation, Performance and Performance Support
• Raw Material Testing, Specification and Testing Documentation
• Review and Update of Testing Procedures for Final Products
• Method Validation for Row Material and Final Product Testing
• Bioburden Control Strategy, Concept and Requirements Support
• Cleaning Validation, Concept and Requirements Support
• Internal Audits (QC Laboratories, LSO Recall-Process)
IMPD Submission Project Support
- Biedenkopf, Germany, Biotech Product, US requirements
• Review & Summary Method Validation, IMPD-Submission
Process Validation Project Support
- Boca Raton, USA, Product Downstream, US requirements
• Review and Assessment of Process Validation Documentation
• Process Validation Concept and Requirements Support
Regulatory Project Support
- Frankfurt, Germany, Downstream & Filling Processes, EU & US requirements
• Review & Assessment of Final Reports for Submission, Qualification & Validation Documentation
Cleaning Validation Project
- Vienna, Austria, Solida Production, EU & US requirements
• Cleaning Validation Concept and Documentation
• Analytical and Swab Sampling Method Validation
• Project Management Support, Sub-Project Manager CV
GMP Support Project: Production Plant and Utilities
- Vienna, Austria, Downstream Processing, Utilities, EU & US requirements
• Project Management of Commissioning and Qualification Tasks
• Risk Assessment GMP, Product, Environment, Health and Safety
• FAT, SAT, Qualification Documentation
• Change Control & Deviations: System Definition and Management
Process Validation Project, Lyophilization
- Marburg, Germany, Lyophilization, EU & US requirements
• Process Validation Concept and Requirements Support
• Generation of Process Validation Documentation
• Generation of Reports for Authority Submission
Qualification Project: Packaging Machine
- Vienna, Austria, Solida Production, EU & US requirements
• Qualification Concept and Documentation
• Review and Assessment of Vendor Documentation
• Qualification Performance and Final Report
• Project and Change Management
De-Bottlenecking Project
- Basel, Switzerland
• Assessment of potential Yield Improvement Capabilities in regard to
• Regulatory and Inventory Impact, Business Risk and Phasing
• Estimation of Costs and Benefits
Contract Filler Technology Transfer Project
- Manchester, GB, Aseptic Contract Filling, EU & US requirements
• Technology Transfer of Aseptic Filling Process
• On Site - Project Management Support
• Establishment of Compliant Process Documentation
• Review and Assessment of Qualification and Validation Documentation
• Review of Quality Systems (Change Control & Deviation Management, Qualification & Validation),
Evaluation of general GXP-Compliance Status
Documentation Review Project: Granulation Equipment
- Vienna, Austria, Solida Production, EU & US requirements
• Review and Assessment of Vendor Documentation
• GAP Analysis
Cleaning Validation Project
- Vienna, Austria, Solida Production, EU & US requirements
• Project Management, Project Manager
• Cleaning Validation Concept and Documentation
• Analytical and Swab Sampling Method Validation
• Revalidation and Change Management Concept
• Validation Performance and Final Reports
FDA Pre Approval Inspection Support Project
- Nottingham, GB, API-Manufacturing and Filling, EU & US requirements
• Audit Preparation & Support (FDA PAI)
• General GXP-Compliance Status
• Review of Quality Systems