:Review Master Batch Records, perform Batch Record Review and generate supporting documentation for batch releaseReview and manage deviations, investigations and complaints, in collaborations with all relevant functionsSupport the organization of technical and managerial meetings with clients and participate in customer visits and audits by customers and/or regulatory authorities.Contribute to achieving "zero past due" objectives in Quality (CAPA, Complaints, Deviations) within one's scope of responsibility, as well as RFT (Right First Time) and OTD (On-Time Delivery) objectives for document submission to the client and lot release.Provide quality support to customers by responding to inquiries.Conduct training for personnel involved in Quality activities for PDS.How will you get there?Required Skills and Experience:Degree in Chemistry/ CTF/ Biological Sciences or similar fieldsMulti-year experience in Quality Assurance Operations teams, with a focus on deviation management and support to GMP manufacturingExcellent knowledge of GMP and national/international regulationsAbility to write, handle and review GMP documentation (Quality Agreement, CAPA…) and understanding of main quality indicators such as RFT (Right First Time) and OTD (On-Time Delivery).Good problem-solving abilities, excellent communication and team working skills and ability to prioritize under time constraintsItalian and EnglishThermo 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.ACCESSIBILITY/DISABILITY ACCESSJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
