When you’re 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
The pharmaceutical manufacturing plant in Ferentino (80km from Rome), with more than 850 employees, is specialized in commercial contract manufacturing of injectable drugs, both liquid and lyo, with an increasing focus on biologics.
 
How will you make an impact?
You will be part of a dynamic and result-driven environment and, as a Team Leader, Process & Cleaning Validation within QO Deviation, Process & Cleaning Validation Department. The Team Leader coordinates and manages his team to handle multiple projects to provide documented validation of manufacturing processes (Media Fill, Cleaning and process validation).
 
What will you do?             
 

• Managing multiple projects to provide documented validation of manufacturing processes (Media Fill, Cleaning and process validation);
• Write, execute, and close validation documents (Media Fill, Cleaning and process validation);
• Define criteria and scope of process validation activities in compliance with regulatory requirements through Validation Master Plans, corporate policy, SOPs and Regulatory Dossiers;
• Initiate, review, update, and/or complete GMP documentation as required (e.g. Risk Assessments, Change Requests, Standard Operating Procedures, Work Requests, Investigations, and Deviations);
• Ensure quality, accuracy, and completeness of validation documentation and deliverables;
• Evaluate and determine required validation testing;
• Define and manage timelines to ensure to meet the clients/Company goals and constantely track status of validation activities and documentation;
• Interface with internal and external clients as Subject Matter Expert (SME);
• Participate in internal and external audits as Subject Matter Expert (SME);
• Provide leadership and supervise activities and work assignments for process & clenaing team;
• Set development plan for direct reports

• Scientific bachelor degree;

• 3-5 years of experience in QA fields;
• Knowledge of Aseptic processing;

• Innovative, decisive, results oriented leader with strong coaching and problem-solving skills;
• Ability to exercise risk-based decision making to determine appropriate action;
• Ability to multitask and priority managing
• Very familiar with FDA, GMP, and ISO standards;
• Proficient in Microsoft Word, Excel, and Outlook;

 
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.