Audit Specialist

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Due to a growing portfolio, we are currently looking for a Audit Specialist to be based in Serbia OR Lithuania.

Your time here

At Parexel, our Audit Specialist have the experience and knowledge to provide guidance and facilitate the effective preparation, management and follow up of Sponsor Audits and Regulatory Inspections.

Key Accountabilities:

- Liaise with the Sponsor and Parexel project team, Quality Assurance Management and staff, throughout the lifecycle of an SAI
- Conduct all preparation meetings, assign tasks with other internal departments and gather necessary information on Sponsor confidentiality agreement documentation.
- Initiate planning process(es), e.g., project plans with deadlines and milestones, to manage an SAI effectively and seamlessly
- Ensure SAIs are performed to a high degree of client satisfaction and regulatory requirements
- Build, develop, and maintain good working relationships with internal and external customer groups
- Determine most appropriate setting to host an SAI, based upon requirements
- Actively support the host throughout a an SAI, as applicable
- Support Non-Parexel-facility audits and inspections (i.e.. investigator sites, supplier sites, sponsor offices, as applicable
- Ensure that Technical Enterprise Tools e.g., extranet, PMED, PMEX and Microsoft Teams are set up correctly, are tested and tailored to the Sponsors specific requirements
- Summarize quality events arising from sponsor audits and other related activities, as requested.

Skills:
 Ability to confidently and diplomatically address sensitive issues professionally
 Excellent interpersonal, verbal and written communication skills
 Experience with Microsoft based applications and ability to learn internal computer systems
 Flexibility and ability to adjust to changing priorities and unforeseen events
 Excellent time management skills and the ability to follow-up on multiple tasks and projects
 A team player with a positive attitude
 Ability to work consistently in a fast-paced environment

Knowledge and Experience:
 Significant experience in Quality Assurance, auditing, relevant Quality Management and clinical trial support
 Strong knowledge of GxP, industry standards, applicable regional regulations

 MS Office standard application skills required (MS Teams, Word, Excel, Outlook)

Education:
 Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
 Strong command of written and spoken English language and local language proficiency

Note:

Pharmacovigilance background preferred for this req.