Thermo Fisher Scientific, Pharma Service, plant in Monza is a world class contract manufacturing facility, specialized in aseptic injectable drugs.
Joining more than 1900 colleagues on site, the selected candidate will experience a smart, driven, and fast-growing environment.
How will you make an impact?
As a Sr. Change Control Specialist, you will join the Quality Assurance unit to act as internal and external point of contact for the change management process.
Supporting your Team Leader, you will be responsibile for the management of changes through the review, coordination of activities and closure of the change in Global TrackWise System,
Acting as the point of contact for our Clients, you will actively take part in meeting calls to facilitate the change control review process, and to discuss approaches and ongoing actions.
In this role you will enjoy an unmatched visibility on a state of the art sterile manufacturing site and exposure to world-class Clients, where your ability to lead technical discussions and to effectively comunicate in english will make the difference.
What will you do?
Evaluate the technical documentation relating to the proposed changes in order to acquire the information necessary for the review of change controls in compliance with company procedures and for the risks identification and evaluation of mitigation actions .
Control of change control :
Manage change controls relating to raw materials, processes, plants, products in compliance with deadlines and company procedures;
Collect change control requests from other company functions, assess their impact on the current GMP status, review the action plan for the implementation of change control and the closing report.
Interact with all internal functions in order to perform a complete change control assessment
Interact with customers for change control topics (change control review, monitoring and implementation)
Improvement of Change control management process
How will you get here?
Degree in Pharmacy / CTF / Biological Sciences / Chemistry / Industrial chemistry / Chemical engineering / Biotechnology
Experience in Quality Assurance in Pharma / API Industry : change control, deviations, recalls, CAPA, SOP, Quality on the Floor, suppliers, APR
Fluent English / Italian fluent (English at B2 level is required)
Professional knowledge of MS Office (particularly Excel) and Quality Management Systems like Trackwise
Superior communication skills and ability to partner with key stakeholders
Attention to details