pharmaceuticalcompany Dettagli sul cliente pharmaceuticalcompany Descrizione Responsibilities : · 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.
Technical skills : - 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.
Personal skills : - 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 Permanent Contract.