Quality Assurance Auditor (GCP)
PSI CRO
Bucharest, Romania
3 zile în urmă

Company Description

We’re over 2,000 strong across the globe. We’re scientists, strategists, creatives, and innovators. We value individual brilliance and build a strong foundation for teamwork across all areas of our business.

We love the challenge of our industry. We’re changing lives and redefining success every step of the way.

You are dynamic. You are curious. You are more than your job. For you, excellence isn’t just a word; it’s the measure for all you do.

You’re passionate. Driven. Dedicated. You can’t stand mediocrity. And you might just be the team member we're looking for.

Job Description

We are looking for a Quality Assurance Auditor to join us as part of a tight-knit, international team, working across multiple locations and time zones.

You will ensure high quality standards within our clinical trials and internal company processes, and share your expert knowledge with the business.

This is an excellent opportunity to work in multiple therapeutic areas and gain exposure to all aspects of the clinical trial process.

Your responsibilities will include :

  • Preparing, conducting, and reporting of QA study audits, internal systems and location audits, vendor qualification audits and maintain relevant communication with the auditee
  • Communicating with project teams with regard to QA study audits, including follow-up and resolution
  • Assembling QA audits documentation
  • Training PSI Operations staff in quality management topics
  • Please note, this role requires international travel for site audits.

    Qualifications

    What are we looking for?

  • MD, PharmD or degree in life sciences is a plus
  • A minimum of 3 years’ experience in quality management or quality assurance
  • Must have experience in planning, conducting and reporting of QA audits
  • Excellent knowledge of ICH GCP guidelines, EMA and FDA regulations, and applicable local laws / regulations
  • Team oriented with superior communication and interpersonal skills including a proactive attitude to tasks and projects
  • Excellent time management skills
  • Demonstrated ability to meet tight deadlines, multi-task / be flexible and thrive in a fast-paced work environment
  • Full working proficiency in English
  • Proficiency in MS Office applications
  • Ability to travel
  • Additional Information

    If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

    We have a generous benefits package here at PSI as we understand the importance of giving back to our employees. Our benefits are focused on providing you with the support to excel both at work, and in your personal life!

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