QA/qc Change Control Advisory Specialist

2 settimane fa


Frascati, Italia Particle Measuring Systems A tempo pieno

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.
Do you have a true passion for the Pharmaceutical or Electronic industries and for delivering the best solutions for our customers?_

QA/QC CHANGE CONTROL ADVISORY SPECIALIST
- What you will do:_
- Provide a full range of technical advisory services to our customers related to Change Control, Quality Compliance, Sterility Assurance, and Quality Control in Pharmaceutical Manufacturing.
- Provide risk management activities at our customer sites to reduce or eliminate any risk of non-compliance with regulatory requirements.
- Manage and deliver project tasks in a timely manner in order to guarantee profitability and customer satisfaction.
- Develop business solutions that meet the specific needs of the customer using experience, best practices, and knowledge of the client's business and the sector's main drivers.
- Generate new business leads.
- Provide interpretation, support & training within and outside the company regarding FDA, GMP, and ISO standards and regulations.
- Support marketing and product development activities for the advisory product range.
- Relevant Education and Requirements:_
- 3 years + experience in Quality Assurance, Quality Control, and/or Sterility Assurance is required.
- Previous experience as Change Control Coordinator, Deviation Manager, and/or Quality operation is considered a plus.
- Microbiological and environmental monitoring background.
- Deep knowledge of GMP regulation.
- Degree in scientific disciplines such as Biology, Biotechnology, Biomedical Engineering, Microbiology or Chemistry and Pharmaceutical Techniques.
- Fluency in English.
- We expect the Advisor to travel 30-40% of his/her time on average in a standard month.

Join us and be yourself. Inclusion is our ambition

Our recruiting team is looking forward to getting to know you

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.



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