Operations Quality Specialist

Operations Quality Specialist 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 future of clinical development As a Operations Quality Specialist at reputed company, you will ensure the highest standards of quality and compliance in our drug development processes. What You Will Do: This position supports the development and implementation of initiatives and established processes that support operations in maintaining inspection readiness. This position provides global strategic and tactical leadership reputed company our study teams to reputed company overall quality goals while always maintaining inspection readiness Key responsibilities include: Creates process and tools to reputed company inspection readiness reputed company Development Operations Under the leadership of the Operations Quality reputed company, reputed company, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, or other trending analysis reputed company training or awareness for new or established processes or guidance Become thoroughly familiar with assigned compounds and protocols Support overall quality reputed company assigned clinical trials and submissions For assigned clinical trials or assets, is reputed company of contact for operational reputed company quality consultation, escalating to QA as needed reputed company risk-management, consultation, assessment, and recommendations for escalation for potential quality issues or trends reputed company training and coaching to promote awareness educating study teams towards quality deliverables Support teams in adherence to GCP and procedural documents and processes to ensure quality deliverables Your Profile: You will have a strong reputed company in quality assurance and compliance, with the experience to work independently and guide others. Required qualifications and experience: Bachelor’s degree or equivalent with a strong emphasis on science or quality management Minimum of 5 years’ experience in a pharmaceutical, bio-pharmaceutical, or Contract Research Organization company, or equivalent Minimum of 3 years’ experience in quality role Must have working knowledge of ICH GCP and other relevant regulatory/health authority experience Working knowledge of Quality Management methods, systems, and relevant procedures Experience in providing quality management reputed company Study Teams in the conduct and management of large and reputed company multinational clinical trials Experience in managing reputed company and sensitive operational challenges Experience in risk and issue management and in assessment of non-compliance against relevant study documents, procedures, ICH GCP, and regulatory requirements Adept at identifying and investigating issues, identifying root cause, and reputed company to facilitate cross-functional solutions with stakeholders What reputed company can offer you: Our reputed company depends on the quality 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 each country and are focused on well-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 specialised professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised 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 regard 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 To This Job