APR & CPV Specialist

TN Italy; Monza; In loco; EUR 40.000 - 80.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking an APR & CPV Specialist to join their team. In this role, you will be responsible for drafting critical reports and conducting comprehensive data analysis within the pharmaceutical sector. Your expertise will enable the successful implementation of Annual Product Review Reports, ensuring compliance with regulatory guidelines while collaborating with cross-functional teams. This position offers a unique opportunity to contribute to a world-class organization dedicated to improving global health through innovative solutions. If you are detail-oriented and passionate about making a difference, this role is perfect for you.

Competenze

• Proven track record in data analysis and report writing in the pharmaceutical industry.
• Strong knowledge of regulatory guidelines (GMP, FDA, EMA).

Mansioni

• Drafting Annual Product Review Reports and conducting trend analysis.
• Evaluating technical documentation for Risk Assessments.

Conoscenze

Data Analysis

Report Writing

Attention to Detail

Regulatory Guidelines Knowledge

Statistical Tools Proficiency

Communication Skills

Strumenti

Statistical Software

Descrizione del lavoro

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As a APR & CPV Specialist, you will be responsible for the following:

1. 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 trend analysis of monitoring data 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 APR data.
• Gathering information necessary for writing specific product Risk Assessments for CPV.

Definition of CPV Protocols

• Drafting monitoring protocols for CPV by researching and acquiring data from various company functions.
• Following company procedures to establish protocol contents.

CPV Reports

• Analyzing data collected from batches, including process parameters and analytical results, using statistical tools and following company protocols.
• Drafting accurate CPV reports to communicate analysis results.

Job Requirements

To succeed in this role, you should meet the following requirements:

• A proven track record in data analysis and report writing within the pharmaceutical industry.
• Exceptional attention to detail and the ability to identify trends in complex data sets.
• Strong knowledge of regulatory guidelines (GMP, FDA, EMA, etc.).
• Proficiency in statistical tools and software.
• Excellent communication skills and the ability to collaborate with cross-functional teams.

Join Our Team

If you are a dedicated professional seeking to contribute 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 impact our success.

About Thermo Fisher Scientific Inc.

At Thermo Fisher Scientific Inc., we are committed to empowering our customers to improve global health, environmental safety, and cleanliness. Through innovative solutions and advanced technologies, we aim to provide high-quality products that meet stringent standards. Join us in leading the industry and advancing scientific progress for positive global change.