Senior Quality Assurance Auditor

hace 5 días

Alcobendas, España Parexel A tiempo completo

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.

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

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