Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description As an APR & CPV Specialist, you will be responsible for the following:
Annual Product Review (APR) Reports Collecting production data, analytical results, and all relevant information to draft the Annual Product Review Report for commercial products. Analyzing data collected from batches produced, including process parameters and analytical results, using statistical tools. Successfully implementing the Annual Product Review Report for the specific product. Periodic Review Reports for Utilities Gathering all necessary information, such as validations, change control, specifications, analytical methods, and analytical results of monitoring, to draft the Periodic Review Report for Utilities. Conducting t of monitoring trends when applicable. Ensuring the completion and accuracy of the Periodic Review Report. Risk Assessment for Continued Process Verification (CPV) Evaluating technical documentation related to manufacturing process validation, product specifications, and Annual Product Review data. Acquiring information necessary for writing specific product Risk Assessments for Continued Process Verification. Definition of CPV Protocols Drafting monitoring protocols for CPV by researching and acquiring data and information from various company functions. Following company procedures to establish the contents of the protocols. CPV Reports Analyzing data collected from batches produced, including process parameters and analytical results, using statistical tools and following company protocols. Reporting the results of statistical analysis and related assessments through accurate drafting of CPV reports. Job Requirements To succeed in this role, you should meet the following requirements:
A consistent record in data analysis and report writing within the pharmaceutical industry. Exceptional attention to detail and the ability to identify trends and patterns in complex data sets. Strong knowledge of regulatory guidelines and standards (GMP, FDA, EMA, etc.). Proficiency in statistical tools and software. Excellent communication skills and the ability to collaborate effectively with cross-functional teams. Join Our Team If you are a high-reaching professional looking to give to a world-class organization and make a difference in the pharmaceutical industry, we invite you to apply for the APR & CPV Specialist position at Thermo Fisher Scientific Inc. We offer a collaborative and inclusive work environment where your expertise will be valued, and your contributions will have a direct impact on our success.
About Thermo Fisher Scientific Inc.
At Thermo Fisher Scientific Inc., we are committed to empowering our customers to improve global health, environmental cleanliness, and safety. Through our inventive solutions and advanced technologies, we aim to provide impeccable products that meet the most stringent quality requirements. Join us in our quest to lead the industry and give to scientific progress that brings positive change to people worldwide.
Join us!
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