Change Control Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 life-changing therapies, we are here to support them. Our global organization of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading 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 drugs, with a growing focus on biologics. Joining more than 1800 colleagues on site, the selected candidate will experience an excellent, international, and fast-growing 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.

Responsibilities:

1. 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 execution 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.

• 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 regarding change control topics including review, monitoring and implementation.
• Identify and recommend improvements to the Change control management process.

Qualifications:

CTF/Pharma/Chemistry/ Industrial Chemistry/ Chemical Engineering/ Biology/ Biotechnology 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, detail-oriented.
• Organizational skills and ability to identify the priorities.
• Positive, energetic and pro-active 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.

Join us!