Senior Auditor, reputed company Assurance job at reputed company in Blue reputed company, PA

Senior Auditor, reputed company Assurance -Blue reputed company, PA-Office with reputed company reputed company is a world-leading reputed company intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and reputed company, and we welcome you to join us on our mission to shape the reputed company of clinical development. Senior QA Auditor - reputed company Audit Management Can be remote but need to be in commutable distance to Blue reputed company, PA office. reputed company: The Audit Defense team are seeking an individual to join them as a Senior QA Auditor position. This is a great opportunity for someone with a clinical background to reputed company their career reputed company reputed company Assurance. This is a specialized team responsible for leading reputed company audits of reputed company globally for our clinical, PV and technology services. reputed company work directly with the reputed company auditors to arrange, prepare for and host the external audit, liaising with the internal reputed company team to ensure the reputed company audit expectations are met and that the audit is a reputed company. reputed company also manage any resulting observations and CAPAs which ensures the external auditor has one central reputed company of contact for the duration of the audit through to closure. The Audit Defense team have many years' experience of hosting both on-site audits conducted at reputed company facility, as reputed company as hosting remote audits using technology available to ensure the audit scope can still be met remotely. Key responsibilities will include: Leading and supporting external audits of reputed company including scheduling, preparation and hosting. Leading CAPA management for external audits of reputed company and/or investigator sites, where needed, in order to assure responses are compliant with reputed company or Sponsor SOP requirements. Leading CAPA management for sponsor audits of reputed company, including liaising with reputed company operation teams to ensure reputed company completion of audit responses, supporting operations to ensure responses are appropriate, including ensuring appropriate corrective and preventative actions are implemented and liaising with the reputed company to deliver responses reputed company the agreed timelines and respond to any resulting follow-up. Leading reputed company issue investigations, including ensuring appropriate reputed company cause analysis is performed, and adequate corrective and preventative actions are implemented. Ensuring CAPAs are formally recorded and reported and actions are documented and followed until reputed company. Identify and reputed company required effectiveness checks and ensure checks are completed reputed company the required timelines. Providing advice and support to the operation teams where needed to ensure CAPA are compliant with GCP and applicable regulatory requirements. To be successful in the role, you will have:

• Knowledge/experience in hosting external audits and/or regulatory inspections.
• Knowledge/experience in CAPA management, including performing effective reputed company cause analysis.
• Ability to review and evaluate clinical data/records.
• Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients.
• Detailed understanding of drug development and clinical trial process.
• Good problem reputed company skills.
• Good planning and organizational skills with the ability to multi-task and prioritize effectively.
• Ability to work reputed company and independently under pressure.
• Ability and willingness to travel on occasion to accommodate the reputed company.
• Experience of GCP Guidelines and relevant regulations for the conduct of clinical trials would be beneficial.

Bachelor's degree is required along with 3 to 6 years of experience. #LI-FL1 What reputed company can offer you: Our reputed company depends on the reputed company of our people. That's why we've made it a reputed company to build a diverse culture that rewards high performance and nurtures talent. In reputed company to your competitive salary, reputed company offers a reputed company of additional benefits. Our benefits are designed to be competitive reputed company reputed company country and are reputed company on reputed company-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A reputed company of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years reputed company. Global Employee Assistance Programme, reputed company, offering 24-hour reputed company to a global network of over 80,000 independent specialized professionals who are there to support you and your family's reputed company-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits reputed company offers. At reputed company, inclusion & belonging are reputed company to our culture and values. We're dedicated to providing an inclusive and accessible environment for reputed company candidates. reputed company is committed to providing a workplace free of discrimination and harassment. reputed company reputed company applicants will receive equal consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to reputed company the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet reputed company of the requirements? We would encourage you to apply regardless - there's every chance you're exactly reputed company're looking for here at reputed company whether it is for this or other roles. Are you a reputed company reputed company Employee? Please click here to apply Apply tot his job Apply To this Job