Metrology Manager

il y a 1 semaine


MontSaintGuibert, Belgique CLINIGEN CLINICAL SUPPLIES MANAGEMENT BELGIUM Temps plein

Define a planning for the maintenance of all equipment, infrastructure

Be responsible for all aspects of Metrology & EMS within the Facilities department

Be responsible for the organization, prioritization and distribution of tasks of the Metrology and EMS department

Maintain and oversee training of the Metrology & EMS team members

Define the key objectives of the Metrology & EMS division in line with CCSM objectives and implement those in the department

Maintain a close relationship with operational departments to provide support and meet their needs

Collaborate with the Management to address, find and solve any problems occurring on the equipment

Define a planning for monitoring of equipment / production facilities

Follow-up and implementation internally, or via subcontractors

Define a planning for monitoring of environmental monitoring system

Follow-up and implementation internally, or via subcontractors

Write documents, URS, IQ/OQ/PQ of new installations and ensure the qualifications/validations of those installations

Provide support to operational departments in terms of qualification and validation both annually and for new systems, equipment or infrastructure in line with our quality standards and GxP regulations

Collaborate with the Quality and Operations departments to ensure compliance / write SOPs, WI, and all other documents necessary to perform annual monitoring of equipment/system and installation within his/her areas of responsibility

Monitoring new technology

Ensure a regular reporting of the facilities metrology department activity to hierarchy

Work closely together with the Facilities Maintenance Manager for all planning purposes

Write/update required QMS documents for the department

Initiate and follow-up on required change controls of the department until close-out

Come up with solutions to improve processes and performance of our systems/equipment

**Profil**:
GxP Industry Experience in metrology, validation, qualification.(>5yrs)

Experience of the working environment and experience of standards specific to the Pharmaceutical Industry (GxP)

Knowledge of ventilation standards, filtration of clean rooms

Education in the field of clean rooms

Education in Metrology

Capacity for analysis and synthesis

Organizational and planning skills

Good ability to respond and adapt to change

Good ability to cope with unforeseen events

Good People Management