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Senior Quality Assurance Auditor, Warszawa

Client:

Parexel

Location:

Warszawa

Job Category:

Other

EU work permit required:

Yes

Job Reference:

31822b450b73

Job Views:

3

Posted:

02.04.2025

Expiry Date:

17.05.2025

Job Description:

When our values align, theres 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.

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.

Responsibilities:

1. Independently lead, plan, schedule, perform, and report a range of GxP audits across all phases of Clinical Research.
2. Perform and deliver high-quality audits/audit reports within specified timelines/budgets, independently or with limited oversight.
3. Review and identify improvements that enhance the quality and clarity of audit reports.
4. Collect and review responses to audit findings and follow-up/escalate inadequate or delayed responses as necessary.
5. Act as a point of consultancy for Operations and Quality regarding the implementation of adequate CAPAs.
6. Support Serious Breaches (SB) investigations and help oversee project teams regarding critical Quality Events.
7. Provide consultation and interpretation on regulatory compliance to internal/external clients.
8. Support the development, maintenance, review, and improvement of Parexel procedures, systems, and tools.
9. Facilitate client audits/regulatory inspections, as assigned.

Knowledge and Experience:

1. Significant experience in quality assurance, regulatory affairs, auditing, clinical research, etc.
2. Excellent knowledge of Good Practices (GxPs) and relevant regulations related to clinical trials.
3. Experience with using computer systems and software, including Microsoft Office.
4. Detail-oriented with the ability to maintain a big picture overview.
5. Ability to follow up on multiple tasks and 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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