QA Operation Specialist

OMEGA, Inc.; Frascati; In loco; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

Join a leading company in cleanroom monitoring as a QA Operation Specialist. You'll provide quality assurance services to pharmaceutical clients, focusing on sterility assurance and regulatory compliance. Bring your expertise to project execution and training while enjoying a supportive benefits package.

Servizi

Market-aligned pay and incentives

Diverse benefits for physical and emotional wellbeing

Competenze

• 3+ years of experience in Quality Assurance or related fields in a pharmaceutical setting.
• Hands-on experience with Change Control and Deviation Management is a strong advantage.
• In-depth knowledge of GMP regulations.

Mansioni

• Provide expert support in Change Control and Quality Compliance for pharmaceutical manufacturing.
• Perform risk assessments and mitigate compliance risks.
• Deliver training on FDA, GMP, and ISO regulations.

Conoscenze

Quality Assurance

Quality Control

Sterility Assurance

Change Control

Deviation Management

GMP Regulations

Microbiology

Environmental Monitoring

Regulatory Compliance

Project Management

Formazione

Degree in a scientific field (Biology, Biotechnology, Biomedical Engineering, Microbiology, Pharmaceutical Chemistry and Technology)

Descrizione del lavoro

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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.

We are looking for a QA Operation Specialist to join our team and deliver expert quality assurance services to our pharmaceutical clients. This role combines professional advisory, project execution, and training activities, with a strong focus on sterility assurance and regulatory compliance.

• Provide expert support in Change Control, Deviation Management, Quality Compliance, Sterility Assurance, and Quality Control for pharmaceutical manufacturing.
• Perform risk assessments at client sites to identify and mitigate compliance risks.
• Offer hands-on support for the implementation and optimization of PMS solutions, ensuring they are tailored to client needs.
• Manage project tasks to meet timelines, profitability goals, and ensure client satisfaction.
• Design and propose custom quality solutions, drawing on industry best practices and deep sector knowledge.
• Contribute to business development by identifying and pursuing new opportunities.
• Deliver training and guidance on FDA, GMP, and ISO regulations both internally and externally.
• Collaborate with the marketing and product development teams to support QA-related offerings.

Key Requirements:

• 3+ years of experience in Quality Assurance, Quality Control, or Sterility Assurance in a pharmaceutical setting.
• Hands-on experience with Change Control and Deviation Management processes is a strong advantage.
• Background in microbiology and environmental monitoring.
• In-depth knowledge of GMP regulations and compliance standards.
• Degree in a scientific field such as Biology, Biotechnology, Biomedical Engineering, Microbiology, or Pharmaceutical Chemistry and Technology.
• Strong communication skills, with the ability to lead training sessions and speak at industry events.

We offer a permanent contract and a total rewards package that includes market-aligned pay and incentives, as well as a diverse benefits offering to support our employees’ physical and emotional wellbeing.

Join us and be yourself. Inclusion is our ambition!

Particle Measuring Systems is an equal opportunity employer, offering a safe and inclusive work environment, based on mutual respect and the appreciation of uniqueness, guaranteeing equal employment opportunities to all qualified candidates to unleash their full potential.

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.