|Validation Engineer IT
Purpose of the function:
The Validation Engineer IT is responsible for managing IT validations from start to finish (also often referred to as computerised system validation). For …………………. this concerns the validation of IT systems that are typical for pharmaceutical production companies, including ………………………………………. The so-called Process Control systems, such as SCADA systems that are used to control and monitor production lines, also belong to this category.
Main tasks and responsibilities:
Performing GMP impact assessments.
Ensure that the quality requirements from the regulations and …………… standards are translated correctly to the user requirements of a system. Consider requirements regarding Back-up & Restore, Incident Management, Disaster Recovery, Electronic Records and Electronic Signatures.
Determine and implement a validation approach for the system (including any interfaces).
Facilitating so-called Design Verification (or Design Qualification) sessions;
Managing the tests according to a structured and formally established procedure.
Assess and report the test results. Review deviations and corrective measures and coordinate possible re-tests.
Ensure that suppliers comply with Astellas standards for design, documentation and validation.
Minimum HBO level (or thinking level)
Knowledge of the formulation and packaging processes.
Preferably knowledge of Electronic Batch Records Systems, Laboratory Information Systems or systems that are comparable in terms of complexity and degree of integration.
Knowledge of GMP regulations (Eudralex Volume 4, 21 CFR Parts 210, 211 and 11) and ISPE Good Practice Guides (GAMP5).
Knowledge of ICT and Industrial Automation.
Knowledge of System Life Cycle methodologies.
Competences Planning and organizing.
Quality-oriented and accurate work.
Excellent communication skills in word and writing both in English and in Dutch.
Minimum 5 years experience in the pharmaceutical or medical device industry or laboratory.
Minimum 3 years experience with the validation of computer systems in the aforementioned industries.
Experience with the validation of an Electronic Batch Records Systems, Laboratory Information Systems or systems that are comparable in terms of complexity and degree of integration.
Experience with System Life Cycle methodologies.
Recruiting Consultant – Charlie Burgess – 0208 432 6080