Process Validation expert in both the area of pharma and medical devices
Experienced with international clients and authorities
Experienced in Process Transfer to and from CMOs
Select your region & language
Our content and services may vary by location.
)
)
Overview
- Availability
- Asap, 5 days/week, on-site & remote
- Qualification
- M.Sc in Technology Management, B.Sc Biological & Chemical Sciences
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Process Validation, Process Optimization, CSV, Non-conformance management, Quality Management, Design Control, CAPA, Risk Management, FDA, ISO 14971, ISO 13485, 21 CFR 820, Medical Devices, GMP, Pharma
Key-Facts
Extract from previous activities
Pharmaceutical Company, Germany
Consultant Process Validation
Process Validation Engineer for Remediation Project Drug device combination
Development of shelf-life rationales for existing polymer resins
Stability studies
Sampling plans for in-process monitoring
Development of validation plan and OQ/PQ protocols
Bio-Pharmaceutical Company
CQV Engineer
Software Validation of a SCADA System according to local/global procedures
Participation in Commissioning an IQ/OQ of downstream equipment
Leading and organizing media qualification fot the downstream plant
Process Validation
Media fills
Process sterilization
Medical Device Company, Germany
Interim QE Lead for Process Validations
Establishment of new procedures and templates for process validation activities
Development of a DOE to allow reduction of validating equivalent bonding processes
Coaching of the Employees
Identification of “worst case” processes of OQ to ensure commercial representative processes for PQ
Risk- & CAPA management
Gap analysis URS, FMEA
Medical Device Company, Ireland
Interim Lead QA Engineer & Tech Transfer
Interim Lead QE for NPO and tech transfer projects
Insurance of compliance to design control & regulatory standards
Interim Lead QE for UDI implementation
Support of Regulatory Affairs Issues
QMS Support (CAPA, Audits)
Development of Quality Plans and QA procedures
Medical Device Company, UK
Quality Assurance & Regulatory Affairs Manager
Implementation and maintenance of the Quality Management System to applicable quality, design contro and regulatory requirements (ISO 13485, 21 CFR 820)
Interim Design control lead for all NPD projects
Management representative and interim lead for notified body audits
Gap Assessment and Risk management
Bio-Pharmaceutical Company, Switzerland
Senior Design Assurance
International CMC-technology transfer Asia/USA/EMEA
CMO Management
Equipment Qualification, Q-Compliance
Process validation for global market launch
Interim Leadership & Team coaching/support
PPQ-batches
Drug Development
Aseptic Manufacturing
Stability, Process design
Deviations, Change control
Risk assessments
Supplier qualification GMP-audits EMEA/USA/Australia (FDA, EMA compliance)
Pharmaceutical Company, Germany
Process Validation Consultant
Write process validation protocols and reports
Consult on strategy for PV associated aspects
Draft MS-Project plan and Gant-charts for the organization of PV
GMP for medical devices & Quality Risk Management
Assessment of criticality, CAPA-personnel-coaching
Manufacturing, equipment qualification, clean rooms, cleaning validation, product development, complaints, change control etc.