More than 10 years of experience within software quality assurance and validation
Specialized on the pharmaceutical industry
Therefore, experienced with industry-specific programs, e.g. LIMS, HPLC, CDS
Select your region & language
Our content and services may vary by location.
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- IT Specialist Application Development
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Validation, Qualification, Computer System Validation (CSV), Software Validation, Quality Assurance, Testing, Data Governance, Data Integrity, Quality, Risk and Compliance Management, IT Infrastructure Qualification, Pharma
Key-Facts
Extract from previous activities
Pharmaceutical Company, Germany
Software Validation Consultant
Validation support of the subproject manager
Coordination of the technical specifications with the corresponding technical contacts
Development of a software validation strategy concept
Review of existing / new CSV & qualification documents
Creation and revision of SOPs
Support / consulting regarding CSV for partners from engineering
Production and IT in the pharmaceutical sector
Consulting and suggestions for inspection preparation
Support of the technical units in the creation and assessment of further CSV documents and change projects for computerized and plant-related systems
Usability Engineering, Requirements Engineering
Data modeling (ERM, UML, EPK)
Pharmaceutical Company, Germany
R&D Remediation Project Manager
Independent review of practices and validations with regard to compliance with internal requirements according to SOPs as well as relevant standard specifications
Performing IQs and OQs
Review for errors in content and form
Identification and documentation of gaps after review of previous components
Direct consultation with the external service provider to rectify identified gaps
Monitoring of the performance of validation
Deviation management
Review and release of CSV documents
Pharmaceutical Company, Germany
Software Validation Manager
Implementation of software validation
Documentation of validation
Process description
Preparation of a validation plan
Definition of re-validation cycles
Define the target state with relevant departments
Planning and designing the IT landscape for DMS/PLM system implementation
Harmonization of the IT landscape in coordination with the business processes and the required internal and external regulations for medical technology
Control and approve modified product designs
Ensure all DHF compliance
Review test results
Software development activities
Preparation of deviation reports and specifications
Preparation of test strategies
Pharmaceutical Company, Germany
Validation Support
Consulting regarding CSV for partners from the laboratory and IT technology
IT computer system compliance of GxP systems, including LIMS, HPLC, CDS
Identification and documentation of requirements, change control management documents
Preparation and review of CSV and qualification documents for use in regulated environment and compliance in accordance with internal and external regulatory requirements
Support of technical units in the preparation and assessment of CSV documents and change projects for computerized and plant-based systems
Organization and procedure for the validation of computerized systems
Pharmaceutical Company, Germany
Computer and Software Validation Quality Manager
Inventory and classification of software
Risk analyses according to GAMP and FMEA validation master plan
Reviews, creation of documentation templates, creation of test plans
Development of test specifications and test protocols, documentation releases
Review of specifications, consulting and support of system owners during software validation
Creation of validation documentation based on specifications