Job Description

The Technology Quality Assurance Auditor position is open for United Kingdom, Romania, Spain, Italy, Serbia, Poland, Belgium, Netherlands, Czech Republic, Hungary, Ireland, Lithuania, Russia, Ukraine - either home- or office-based

The purpose of this role is to conduct audits for GxP regulated technology and to advice both internal and external clients toward compliance with GxPand other applicable regulations and laws.
As a Technology Quality Assurance Auditor you will effectively lead, manage, develop, and implement assigned projects.

Your responsibilities will include:

Compliance to GxP regulated processes and standards as the fundamental baseline for technology validation and delivery across PAREXEL.

Consulting the business assuring quality across all technology business units to meet critical to quality criteria.

Providing GxP regulatory expertise to ensure technology units adhere to established standards and quality expectations.

Auditingon technology projects to identify and mitigate risks and prevent quality concerns.

Assuringquality of selection of technology solutions in support of delivery of products and services to PAREXEL clients.

Specialized Area:
• Conduct risk-based technology audits across all SBUs, all GxP regulations and phases of Clinical Research
including, but not limited to, product development audits, Computerized System Validation and audits, system
audits audit supplier audits
• Provide support for regulatory inspections and high-risk sponsor audits
• Provide Quality representation on Serious Breach Assessments, Information Security Incidents and technology
related policies and procedures

Key Accountabilities:
• Work independently and as part of the QA team
• Facilitate sponsor audits/regulatory inspections, as assigned
• Fosters a good working relationship with internal and external clients
• Plan and conduct audits, including global and complex assignments, delivering a written report within procedural
time frames
• Proactively provide input to management on audit plans/strategy
• Proactively recognize areas for process/procedural improvements, providing input to management and taking the
initiative, as appropriate
• Maintain and/or develop records/documents for assigned areas
Qualifications

Knowledge and Experience:

Experience as a GxP auditor with a high technology affinity or

Substantial experience in quality assurance and from computer system validation, technical consultant or related or

Experience from regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including applicable GxP auditing or

IT auditor from a highly regulated industry

Skills:

Ability to develop relationships with a culturally diverse group of key stakeholders within Parexel and the client'sbusiness

Excellent interpersonal, verbal, and written communication skills, including experience in making presentations at conferences, meetings, and training sessions

Excellent analytical skills

Ability to manage multiple and varied tasks, and prioritize workload

High degree of flexibility and ability to adjust to changing priorities and unforeseen events

Excellent knowledge of, and working experience with, regulations

Ability to work independently and consistently in a fast-paced environment

Education:

Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience

Bachelor's degree in a science, technology or industry related discipline, preferred

Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.