Sterility Assurance Advisory Specialist, Frascati

3 settimane fa


Lazio, Italia Tn Italy A tempo pieno

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Sterility Assurance Advisory Specialist, Frascati Client: Particle Measuring Systems
Location: Job Category: Other
EU work permit required: Yes
Job Reference: 2445a0733f70
Job Views: 10
Posted: 22.01.2025
Expiry Date: 08.03.2025
Job Description: Do you want to be part of a business that genuinely values entrepreneurialism , innovation , and individual accountability ?
We focus on our customers and are proud of the difference our technology makes.
We partner with some of the biggest manufacturing companies in the world, and our technical innovations are used to enhance well-known brands across multiple industries.

Particle Measuring Systems (PMS) specializes in viable and nonviable particle counters and particle counting solutions that measure and monitor contamination levels in clean and controlled environments.
Since 1972, our knowledgeable and experienced team has been developing innovative technologies to advance the cleanroom monitoring industry.
Led by our technology which provides accurate and reliable results and information for our clients, Particle Measuring Systems is one of the world's leading companies and manufacturers of particle counting instruments, and molecular and microbial monitoring.

We are seeking candidates for the position of:
STERILITY ASSURANCE ADVISORY SPECIALIST The Sterility Assurance and Advisory Specialist will take care of the control and compliance of the procedures while developing a consulting approach with customers, focused on Sterility Assurance and Quality Control in Pharmaceutical Manufacturing.

The Sterility Assurance and Advisory Specialist will have the possibility to apply our organization's consulting models and methodologies, assisting also in the design/improvement of methodologies based on customers' needs.
He/she will also have the chance to provide our clients with specific training aligned with FDA, EMA, GMP, and ISO standards and regulations.
The candidate will perform project management activities, providing for each specific project milestones and tasks in a timely manner with an understanding of issues that may affect project profitability and customer satisfaction.
He/she will carry out risk assessment activities together with our customers with the aim of reducing or eliminating any risk of non-compliance with quality.

The candidate will also interact with our Marketing Department to generate new business and ensure the highest quality of our pharma services.

Relevant Education and Requirements: The candidate must have a management experience of at least 3 years in the areas of Quality Assurance, Quality Control, and/or Sterility Assurance.
He/she should have experience in the field of microbiology and environmental monitoring.
The candidate must also have a deep knowledge of GMP good manufacturing standards, and GDP good distribution practice, as well as a comprehensive understanding of the guidelines of institutions such as FDA and EMA.
A Bachelor's Degree in scientific fields such as Biology, Biotechnology, Biomedical Engineering, Microbiology, or Chemistry and Pharmaceutical Techniques is required; relevant experience may be considered equivalent.
Very good knowledge of English and MS Office is required.
Particle Measuring Systems is proud to be an Equal Opportunity Employer.

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