We have an exciting opportunity for GCP Audit Specialist to be based in Lithuania or Serbia to support Sponsor Audits and Regulatory Inspections.
The Audit Specialist will have the experience and knowledge to provide guidance and facilitate the effective preparation, management and follow up of complex Sponsor Audits and Regulatory Inspections.
They have the authority and decision-making responsibility to drive Parexel departments’ and Project
teams’ Sponsor Audit and Regulatory Inspection preparation activities. Will exhibit a high degree of flexibility and initiative, make decisions during audits in line with Parexel’s QMS, demonstrate the ability to follow up on multiple tasks and projects, and ensure that audits and inspections are hosted with a high degree of expertise and quality.
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:
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