Change Control Specialist

7 mesi fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

Support the Change Control Team Leader in order to ensure optimal management of changes, through the review, coordination of activities and closure of the change in Global TrackWise System, in compliance with company needs and procedures. Support in the execution of training to colleagues and in the preparation and execution of inspections from client and regulatory authorities.

Technical documentation analysis:

- Evaluate the technical documentation related to the proposed changes in order to acquire the information needed 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

CTF/Pharma/Chemistry/ Industrial Chemistry/ Chemical Engineering/ Biology/ Biotechnolgy/ degree, 2 years of experience in Pharma industry, good english level (B2)

Technical Skills:

- Experience in Quality Assurance Department of Pharma/API industry:
change control, deviations, recalls and OOS, OOT investigations, CAPA management.
- Experience with clients and suppliers management is a plus.
- Experience in Microsoft Office and Excel

Soft Skills:

- Team working
- Critical approach, details oriented
- Able to identify the priorities and to organize the activities indipently

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