You are:
Within the Validation & Lab Service engineering group, which is responsible for managing validation, maintenance, and calibration activities of utilities & laboratory equipment and the qualification of computerized systems, you will be involved in:
* Collaborating in the drafting/review of documents (e.g., Validation Plan, Risk Analysis, Traceability Matrices, System Description) and qualification protocols for Computer Systems and/or Equipment;
* Collaborating, reviewing, and/or executing tests for the validation of Computer Systems in accordance with internal procedures and the requirements of 21 CFR part 11 and/or Annex 11;
* Drafting and/or issuing Validation Summary Reports and/or qualification reports;
* Reviewing protocols and reports for validation, calibration, and maintenance;
* Updating and maintaining the risk analysis;
* Ensuring compliance with the requirements imposed for departments operating in controlled environments in accordance with GMP regulations;
* Ensuring the drafting and updating of SOPs related to the belonging group;
* Performing all necessary operations to ensure calibration, validation, and maintenance of laboratory equipment within the timeframes and methods stipulated by current GxP procedures
* Promoting, as far as possible, activities related to "ISO" certifications, ensuring compliance with constraints/references.
Who you are:
* One to three years of experience in managing and producing documents (protocols and reports) on validation and calibration activities for instruments and computerized systems;
* Good knowledge of SAP (calibration, maintenance, and validation modules);
* Excellent written and spoken knowledge of English and Italian;
* Excellent knowledge of the Office suite and use of Project;
* Excellent knowledge of GMP;
* Excellent knowledge of the requirements of 21 CFR part 11 and/or Annex 11 for CS in GMP contexts;
* Good presentation skills during inspections;
* Strong teamwork orientation;