Senior Quality Assurance Auditor (GxP or PV)
When our values align, there's no limit to what we can achieve.
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
- depth understanding and knowledge of Gx
P 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:
P 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
- 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.
- cause audits/
- audits / observed audits with client representatives or other QA auditors.
- up / escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of satisfactory quality are obtained and formally recorded.
P and safety/PV requirements, and implementation of appropriate regulatory requirements.
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 Gx
P auditing
• Excellent knowledge, understanding and experience of Good Practices (Gx
Ps) 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:
- related discipline preferred
If you are ready to join Parexel’s Journey, please apply!
- Informații detaliate despre oferta de muncă
Firma: Parexel Localiția: Bucureşti
Bucureşti Sectorul 1, București, RomaniaAdăugat: 5. 8. 2025
Postul de muncă activ
Fii primul, care se va înregistra la oferta de muncă respectivă!