When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's 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 we're committed to making a difference.
Key Accountabilities:
Lead, Perform and Report audits
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.
Travel internationally for audits as required. Travel time could be up to approx. 60%.
Manage GxP audits
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 Quali