.When our values align, there's no limit to what we can achieve.Due to an expanding portfolio, we have an exciting opportunity for an experienced Quality Assurance Auditor to be based in Eastern Europe .Candidates must have a strong clinical trial background, solid Quality knowledge, at least high-level awareness of statistical programming, and must be able to document this in their CV and demonstrate it in an interview.Within the open position, the QA Senior Auditor will play a crucial role in conducting audits that impact business operations, processes, and systems, contributing to meeting client needs and maintaining high compliance standards.With an in-depth understanding and knowledge of GxP compliance, regulations, Parexel procedures,and processes, the QA Senior Auditor will independently plan, conduct, and manage internal and external audits while mentoring less experienced auditors.They may also act as QA leads for audit programs or clients. Collaborating with QA Management, they will actively contribute to process improvement, streamline processes, identify opportunities, provide consultancy on critical regulatory compliance, and ensure global and regional audit programs are performed effectively, promoting both process improvement and regulatory compliance.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
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