Change Control Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Title: Change Control Specialist

When you are part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals!

Location/Division Specific Information:

Quality Assurance/ Quality System Dept./ Change Control Team

How will you make an impact?

Assure the change control system follows company procedures and timely and reliable management of the process (opening, implementation, and closure). Support to the readiness process for manufacturing and batch release, allowing a timely production and release of the pharmaceutical product.

What will you do:

You will join the Quality System Team to supervise the change control process and state with a particular reference to the production and the batch release.

This role will provide you with the opportunity to lead key activities including:

• Supervise the change control opening phase by verifying the proposed change, its completeness in terms of information and documentation;
• Lead a preliminary assessment of the change proposal and identify the potential impacts in order to accurately address the evaluation process;
• Support in the approval phase, verifying the presence and consistency of all the assessments and of the action plan for the implementation;
• Assure in collaboration with the relevant departments, communication with customers/external agencies (periodic meetings with customers, customer audits, regulatory inspections)

Education

CTF, Chemical/Biological science or similar

Experience

1-2 years in Quality Assurance Depts. function of a pharmaceutical company

Knowledge, Skills, Abilities

Ability to work well independently and in team environment.

Excellent interpersonal, communication and organizational skills.

Strong accuracy and attention to detail.

Experience with Microsoft Word and Excel.

Familiarity with Good Manufacturing Practices

Proficiency with the English language.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.