Validity and Compliance Professional
Our organization is searching for a Validity and Compliance Professional to join the Engineering Department. The chosen candidate will be responsible for ensuring the correct management and execution of actions aimed at guaranteeing full compliance in both the Qualification of Equipment, Utilities and Verification of Safety of Equipment areas.
The main areas of operation will include:
* Management and execution of pre-installation (FAT) and pre-qualification (SAT) phases
* First qualification (in project context)
* Periodic re-qualification within the framework of the VMP of the plant
* Qualification of change in the ambit of change control
The selected professional will also be responsible for managing the maintenance of compliance status in both disciplines and handling related documentation, acting as a reference point for regulatory bodies and inspectors during inspections and audits.
This figure will organize qualification and safety verification activities in accordance with company standards on cGMP and workplace safety, supporting the Engineering and Maintenance departments in maintaining the required level of compliance from internal and external clients.
Key responsibilities include:
* Supervising the drafting of technical specifications and user specifications in the context of projects, with possible revision of operational instructions
* Supporting project managers in ensuring the development and correct implementation of the defined qualification approach in collaboration with the Quality Assurance Office
* Directly executing or coordinating qualification activities through external contractors in the Design Qualification, Installation Qualification and Performance Qualification phases (where applicable)
* Supporting the IT, Engineering and Maintenance departments in Computer System Validation activities
* Supporting relevant offices (Engineering, Maintenance, Quality Assurance, Safety) in defining critical instrumentation, inserting it into the plant's metrology plan and maintaining the calibration status within the plant's scheduled deadline
* Managing and coordinating authorized subjects for the registration, first installation, commissioning and decommissioning of pressure vessels
* Managing and coordinating authorized subjects for periodic verification of critical equipment for safety purposes (pressure vessels, centrifugal extractors, steam generators / parachutes / etc.)
* Managing, supervising and following up on change control progress in engineering project and maintenance contexts (where applicable)
* Participating in investigations regarding deviations and failures of equipment, suggesting mitigations and interventions where necessary
* Participating in the definition of qualification, re-qualification and validation strategies, annual review in terms of GMP and VMP of site performance of metrology and maintenance areas
* Participating in inter-functional committees and working groups nominated by the Plant Management for addressing cross-functional issues
* Contribute to the development of plant standards, suggesting improvements
* Ensure respect for health, safety and environmental regulations in their area of competence
Requirements:
* At least 3-5 years of experience in the chemical-pharmaceutical manufacturing sector or consulting companies in the Engineering & Qualification field
* Consolidated knowledge of relevant regulations, technical standards and guidelines for production processes in cGMP, particularly with regard to active pharmaceutical ingredients (API)
* Preferred degree in Chemical Engineering, Biomedical Engineering, Chemistry or Pharmaceutical Technology
* Good command of English language
* Result-oriented, team player with excellent communication skills
Education:
* High school diploma, preferably in a technical-scientific direction
* Laurea in Ingegneria Chimica, Biomedica, Chimica o Chimica e Tecnologie Farmaceutiche è un requisito preferenziale