Audit Specialist (Sponsor Audits and Inspections)

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.

We have an exciting opportunity for GCP Audit Specialist to be based in Lithuania or Serbia to support Sponsor Audits and Regulatory Inspections.

Job Description:

• Independently lead, plan, schedule, perform, and report a range of GxP audits across all phases of Clinical Research which may include but are not limited to project related audits, system and process audits, supplier qualification and re-qualification audits (including GMP & GLP as well as GCLP accreditation audits), Trial Master File audit,  safety/pharmacovigilance (PV) audits in order to evaluate the quality system against the appropriate regulatory requirements, relevant procedures and applicable guidelines.

• Perform and deliver high quality audits /audit reports within specified timelines / budgets, independently or with limited oversight. Lead or participate in complex audits including for-cause audits/ co-audits / observed audits with client representatives or other QA auditors.

• Ability to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports.

• For area of specialization, work with internal customers and develop and execute strategic audit plans for the area.

• Collect and review responses to audit findings and follow-up / escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of satisfactory quality are obtained and formally recorded.

• Act as point of consultancy for Operations and Quality with regards to the implementation of adequate CAPAs with effective and timely escalation of relevant Quality Events where required.

• Support Serious Breaches (SB) investigations and help oversee the project teams to reach final conclusion regarding the reportability of a critical Quality Event.

• Provide consultation and interpretation on regulatory compliance to internal/external clients, Parexel management, and staff with regards to the implementation of GxP and safety/PV requirements, and implementation of appropriate regulatory requirements.

• Support the development, maintenance, review and improvement of Parexel procedures, systems and tools by providing constructive ideas and suggestions.

• Provide input on QA planning including audit planning and strategy as requested.

• Facilitate client audits / regulatory inspections, as assigned.

Knowledge and Experience:

• Significant experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area such as technology, third party supplier management, including sound experience of applicable GxP auditing

• Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research

• Experience with using computer systems and software, including Microsoft Office

• Auditors must be detail oriented, able to maintain a ‘big picture’ / overview on the project / business

• Ability to follow up on multiple tasks and projects, and to handle confidential information diplomatically.

Education:

• Bachelor’s Degree or other relevant experience required. Life-science, health or industry-related discipline preferred