10 Aug
|
Parexel
|
Bengaluru
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 Oper
📌 Senior Technology Auditor, QA (Bengaluru)
🏢 Parexel
📍 Bengaluru