Quality Assurance Specialist

7 giorni fa

Roma, Lazio, Italia ServiceMaster by Integrity 6099 A tempo pieno

About ServiceMaster by Integrity 6099

We are a leading provider of innovative solutions in the Healthcare industry, dedicated to enriching people's lives with our cutting-edge technologies in Healthcare, Life Science, and Electronics.

Your Role:

We are seeking a highly experienced Quality Assurance Specialist to join our Healthcare Quality team. As a Quality Assurance Specialist, you will play a critical role in ensuring that our computerized systems used in regulated environments comply with regulatory requirements.

Key Responsibilities:

  • Develop and oversee quality assurance processes related to software systems in regulated environments
  • Validate software systems to ensure accuracy and reliability
  • Implement measures to maintain data integrity and security
  • Apply AI principles to optimize quality assurance processes and identify areas for improvement
  • Collaborate with cross-functional teams to develop validation protocols, conduct risk assessments, and provide guidance and training on compliance standards and best practices

Requirements:

  • Master's Degree in a technical scientific field or equivalent
  • At least 3 years of experience in the pharmaceutical industry
  • General knowledge of GMP Regulation for computer systems (EU GMP-volume 4 annex 11; CFR21 part 11) and pharmaceutical industry (EU GMP volume 4, CFR21 part 210, 211)
  • Fluent in spoken and written English
  • Previous experience in complex organizations and international networks is in CSV/digital quality assurance
  • Experiences in Quality area with knowledge on:
    • Computer systems related quality processes (e.g. Change Control, Deviation, CAPA);
    • Computerized system to analytical laboratory (e.g. CDS, LIMS)
    • GAMP guidance
    • GMP Regulation for computer system (EU GMP-volume 4 annex 11; CFR21 part 11) and pharma industry (EU GMP volume 4, CFR21 part 210, 211)
    • Data governance and data Integrity principles
  • Problem solving and team working
  • Precision and control
  • Flexibility: planning and organizing
  • Proactively identify areas for improvement within Quality Systems
  • Knowledge of root cause analysis methodology, Lean Six Sigma and Quality Risk Management

What We Offer:

We are committed to creating a diverse and inclusive work environment that fosters growth and development. As a Quality Assurance Specialist, you will have the opportunity to work with a talented team of professionals who share your passion for quality and innovation.

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