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Sterility Assurance Advisory Specialist
6 mesi fa
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 for 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 have the chance also to provide for our clients, specific training aligned with FDA, EMA, GMP and ISO standards and regulations. The candidate will perform also 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 customers 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 get in contact also with our Marketing Department with the specific aim of generate new business and to 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 is required. 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 of GDP good distribution practice, but also a huge knowledge of the guidelines of institutions such as FDA and EMA. A Bachelor’s Degree in scientific matters such as Biology, Biotechnology, Biomedical Engineering, Microbiology or Chemistry and Pharmaceutical Techniques is required, a lasting experience on this field will be equivalent. Very good knowledge of English and of MS Office is required.Particle Measuring Systems is proud to be an Equal Opportunity Employer.
