Senior Quality Assurance Auditor (GxP or PV)
Senior Quality Assurance Auditor (GxP or PV)
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Job Description
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds 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 were committed to making a difference.
We have an exciting opportunity for an experienced Quality Assurance Auditor to be based in selected European countries.
Within the open position the Senior QA 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:
Bachelors Degree or other relevant experience required. Life-science health or industry-related discipline preferred
If you are ready to join Parexels Journey please apply!
Required Experience:
Senior IC
Employment Type
Full Time
