Computerised Systems Validation Specialist (PHARMA - GMP)
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Knowledge and full compliance with the quality management system according to:
Good Manufacturing Practice for Medicinal Products for Human Use (GMP), Veterinary and Clinical Investigation Medicines (MIC)
Study: Politehnica University of Bucharest
knowledge of English-advanced level
Departament : Quality assurance
Train staff in terms of GMP provisions for human and veterinary medicinal products;
Elaborates standard operating procedures specific to the general activity of the Quality Assurance Department
Prepares the written documentation in order to implement and / or improve the quality assurance / management system according to the Good Manufacturing Practice.
Participates in tests in order to qualify / validate installations and equipment and processes
Revises / improves standard operating procedures and qualification / validation protocols, in order to update them in accordance with the regulations in force.
He is part of the team that ensures the fulfillment of the annual metrological calibration / verification plan, both by executing or coordinating the internal calibrations, and by collaborating with the metrological verification offices.
Prepares reports and plans for efficiency and improvement of the qualification / validation activity, of the tests and of the testing methods at the request of the head of the validation team and of the Quality Manager
Participates in the elaboration of the annual validation / qualification plan
He is part of the team that elaborates, completes and executes the evaluations regarding the data integrity and the management of the computerized systems
Recommends corrective actions in order to solve the deviations resulting from the validation of the systems / processes.
Provides technical assistance and recommends solutions for resolving deviations from qualifications / validations.
Collects, leads and analyzes information and recommends measures that can be taken to improve the performance of validated systems / processes.
Ensures the analysis of the impact on the control of the change in validation
Monitors the implementation of changes.
Provides support for the validation process of computerized systems;
Participates in the process of remedying the differences of the company's computer systems compared to the data integrity requirements;
Check the observance of the regulatory requirements regarding the data integrity of the computerized systems