Change Control Specialist

Work Schedule

Environmental Conditions

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier cleaner and safer. Whether our customers are accelerating life sciences research solving sophisticated analytical challenges growing efficiency in their laboratories improving patient health through diagnostics or the development and manufacture of lifechanging therapies we are here to support them. Our global organization of more than 100000 colleagues delivers an outstanding combination of innovative technologies purchasing convenience and pharmaceutical services through our industryleading brands including Thermo Scientific Applied Biosystems Invitrogen Fisher Scientific Unity Lab Services Patheon and PPD.

Monza site is an outstanding pharmaceutical contract manufacturing and development facility specialized in aseptic injectable with a growing focus on biologics. Joining more than 1800 colleagues on site the selected candidate will experience an excellent international and fastgrowing environment. With revenues exceeding $24 billion and the largest investment in R&D in the industry we give our people the resources and chances to create meaningful contributions to the world.

Join an outstanding team at Thermo Fisher Scientific as Change Control Specialist. This role presents an outstanding opportunity to contribute to our goals by ensuring an efficient management of changes process. You will work in a dynamic environment where your expertise will drive the successful implementation of change controls.

Technical documentation analysis:

Identify any quality risk for the modifications review coordinate the activities and the closure of the change in Global TrackWise System.

Be part of preparation and of inspections from client and regulatory authorities

Evaluate technical documentation related to the proposed changes to determine the necessary information for reviewing change controls. Ensure compliance with company procedures and identify risks and mitigation actions.

Control of change control:

Follow change controls related to raw materials processes plants equipment products correlated to site projects in compliance with company procedures;

Collect change control requests from various company functions assess their impact on the current GMP status review the action plan for the implementing change control and closing report.

Interact with all internal functions to perform a complete change control assessment

Engage with customers regrding change control topics including review monitoring and implementation

Identify and recommend improvements to the 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 Excel or other programs

Soft Skills:

Team working

Critical approach details oriented

Organizational skills and ability to identify the priorities

Positive energic and proactive approach

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race creed religion color national or ethnic origin citizenship sex sexual orientation gender identity and expression genetic information veteran status age or disability status.

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