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Computer System Compliance Auditor

3 months ago


New York, United States Adamas Consulting Full time

Job Description

  • Planning, preparation, conduct, reporting and follow up of various types of audits according to expected quality and timelines

  • Executing audits based on a comprehensive understanding of all regulatory requirements.

  • Performing quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.

  • Assisting with business development activities



    Qualifications:
    Qualifications

  • BSc in Life Science preferred

Experience in conducting and leading internal and external Computer System Compliance audits for a variety of stakeholders

Experience in conducting a range of service provider audits (e.g., computer system validation audits, computer system compliance audits)

Experience in conducting CSC/CSV systems audits.

Experience in coordinating and managing inspection preparation activities om support of regulatory inspections both at the sponsor and CRO.

Expert knowledge of national and international computer system legislation and guidelines

Up to 40% travel and ability to conduct remote audits

Additional Information

Why ADAMAS?

As an organization, we prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? Because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

Training and career development opportunities internally

Strong emphasis on personal and professional growth

Friendly, supportive working environment

Opportunity to work with colleagues based all over the world, with English as the company language.

Our core values are key to how we operate, and if you feel they resonate with you then ADAMAS, an Ergomed Company is a great place to join

Quality

Integrity & Trust

Drive & Passion

Agility & Responsiveness

Belonging

Collaborative Partnerships

We look forward to welcoming your application.