pharmaceuticalcompanyDettagli sul cliente
· Provide specialized assistance to new investment projects development, in the industrial area, also directly following the assigned projects and their execution.
· Draw up and/or check the necessary technical documentation and its completeness (user requirements, specifications, tests, user manuals, etc.).
· Carry out feasibility and improvement studies, if necessary, assisted by specialized engineering companies or other external consultants in the expertise area.
· Set plants layout making sure that it conforms to the process characteristics and meets the criteria of: quality, safety, industrial hygiene and environmental protection.
· Coordinate the activities of the Bulk and Pharma process plant manufacturers, when they are called to carry out the work.
· Participate in the design, installation and machine and plant control systems testing on projects managed by other Project Managers.
· He/she is responsible for its own area of expertise for all activities related to GMP, in particular packaging plants testing and qualification.
· Follow Good Engineering Practice and, when necessary, apply both Good Manufacturing Practice and GAMP guidelines.
· When necessary, provide adequate support for maintenance issues resolution.
· Manage indipendently the assigned investment projects.
· Keeping up to date with the plant engineering and technology evolution of the market and competitors.
· Contribute to processes and Corporate guidelines implementation and distribution at corporate sites.Profilo del Candidato
- Master Degree in chemical (preferred) or electronic engineering.
- Required experience of at least 3 years in the pharmaceutical plants design or management. Preference is given to experience in sterile and biotechnological processes.
- Knowledge of pharmaceutical processes, in particular, sterile production.
· Knowledge of process plants and industrial machines, instrumentation and control devices typical of the pharmaceutical industry.
· Extensive knowledge of pharmaceutical regulatory references (FDA, EMEA, ICH, CFDA, etc.) concerning the environment, plant engineering, production and drugs control.
· Knowledge of the main international pharmacopoeia and GMP (Europe, USA, PIC, WHO) and GAMP guidelines.
· Knowledge of quality systems and standards of ISO:9000:2015, ISO 14000, OHSAS 18000 series.
. Knowledge of technical standards.
· Preparation of test documentation and operating manuals.
· Drug traceability and factory information systems.
· Project Management.
· Knowledge of legislation and general competence in the field of construction and procurement, including authorisation aspects with local authorities.
- Leadership and interpersonal skills.
· Result orientation and planning skills.
· Customer-driven and teamwork skills.
· Preparation for work in a dynamic and multicultural environment.
· Attitude for change.
· Good stress management skills.offerta di lavoro