Quality Assurance Specialist

4 settimane fa

Guidonia Montecelio, Lazio, Italia EMD A tempo pieno

About EMD

EMD is a leading company in the Healthcare industry, dedicated to creating innovative solutions that enrich people's lives. Our mission is to help create, improve, and prolong lives through our medicines, intelligent devices, and technologies.

Your Role

We are seeking a highly experienced Quality Assurance Specialist to join our Healthcare Quality team. As a Quality Assurance Specialist, you will be responsible for ensuring that computer systems used in regulated environments comply with regulatory requirements. This includes writing and overseeing quality assurance processes related to software systems, validating software systems to ensure accuracy and reliability, and implementing measures to maintain data integrity and security.

Key Responsibilities

  • Develop and implement quality assurance processes for computer systems in regulated environments
  • Validate software systems to ensure accuracy and reliability
  • Implement measures to maintain data integrity and security
  • Collaborate with cross-functional teams to develop validation protocols and conduct risk assessments
  • Provide guidance and training on compliance standards and best practices

Requirements

  • Master's Degree in a technical or scientific field
  • At least 3 years of experience in the pharmaceutical industry
  • General knowledge of GMP Regulation for computer systems and pharma industry
  • Fluent in spoken and written English
  • Previous experience in complex organizations and international networks in CSV/digital quality assurance
  • Experience in Quality area with knowledge on computer systems related quality processes, computerized systems in analytical laboratories, GAMP guidance, and GMP Regulation for computer systems
  • Problem solving and team working skills
  • Precision and control
  • Flexibility and ability to plan and organize
  • Proactively identify areas for improvement within Quality Systems
  • Knowledge of root cause analysis methodology, Lean Six Sigma, and Quality Risk Management

About You

We are looking for a curious and innovative individual who is passionate about quality assurance and data integrity. You should have a strong background in the pharmaceutical industry and experience in complex organizations and international networks. You should also be fluent in spoken and written English and have a strong understanding of GMP Regulation for computer systems and pharma industry.

What We Offer

We offer a dynamic and inclusive work environment that values diversity and innovation. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress.

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