This candidate provides long-term experience in Commissioning, Qualification and Validation in manufacturing environment
The candidate has a strong hands-on mentality and supports the clients in the full range within qualification and validation (DQ, IQ, OQ, PQ)
Deep knowledge of revision and creation of qualification documents (e.g. Master Validation Plan, Risk Documents, SOPs)
Select your region & language
Our content and services may vary by location.
)
)
Overview
- Availability
- Asap, 5 days/week, on-site & remote
- Qualification
- Mechanical Engineer, Diploma
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Qualification and Validation Engineer, Commissioning, DQ, IQ, OQ, PQ, Equipment Qualification, Production Process Validation, Qualification Documentation, SOPs, Risk Analysis, FMEA, ISO 13485, 21 CFR 820, Medical Devices
Key-Facts
Extract from previous activities
Medical Device Company, Germany
Interim Qualification Manager
Revising qualification documents (Master Validation Plan and Risk Analysis) for a new production plant for medical devices
Support for validation and qualification activities for a manufacturing plant
Checking supplier qualification documents
Managed qualification document approvals
Deviation and Change Management
Medical Device Company, Germany
Validation Consultant
Validation of multi-purpose equipment for a new manufacturing plant for Dry Powder Inhaler
Perform commissioning and validation activities
Scope of work included defining validation strategy
Planning and executing Risk analysis (RA)
Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ)
Implementing testing schedules
Preparing DQ/IQ/OQ protocols
Field execution and development of test specifications
Medical Device Company, Germany
Equipment Qualification Manager / Process Validation Manager
Responsible for equipment qualification and process validation of medical device manufacturing
Qualification of ceramic working lathes
Consulting on the compliance with clean room regulations for medical devices
Preparation of Validation Master Plan
Preparation of IQ/OQ/PQ plans and protocols
Execution of IQ/OQ/PQ protocols
Responsible for data assembly and interpretation
Medical Device Company, Germany
Validation Expert
Definition of validation processes
Consulting for complete documentation of validation processes including external partners and suppliers
Support in the qualification of test equipment
Operational support of ongoing validation activities with focus on risk management (design and process FMEA)
Medical Device Company, Germany
Qualification & Validation Consultant
Responsible for the release of qualification/validation documents (plans and reports) as part of the process validations within a relocation process
Professional support/consulting for processes and collaboration in the preparation of risk analyses
Permanent optimization of workflows to increase quality and efficiency increase