eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.
You will make an impact:
As a GCP Auditor, you will play a key role in the Internal Audit and CAPA Management Programs and serve as the lead for Sponsor and Vendor Audit activities, quality metrics compilation, analysis, trending and reporting, and facilitation of, issues escalated to leadership, as well as Quality Improvement activities.
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.
Your day to day:
- Client Audit Hosting and Internal Audit activities, including follow up on the resulting actions
- Complete Internal audit activities related to Delivery and Process audits
- Ownership of managing the Quality Management System process gaps and needed improvements focused on the Services Organization which can be internally driven or a result of audit feedback
- Work collaboratively across various functional organizations including India Operations
- Inform senior management of any non-compliance incidents or regulatory compliance issues, which may arise internally or from external customers
- Remain abreast of and apply updates to regulations, guidelines, and principles related to Good Clinical Practice and provide advice on their use and compliance
- Work with company compliance experts by identifying quality issues and trends across various functional departments and establishing action plans for resolution
- Assist in the review and approval of QMS procedures
- Other duties as assigned
Take the first step towards your dream career. Here is what we are looking for in this role.
Qualifications:
- Bachelor’s degree or equivalent work experience preferred
- 5+ years Pharmaceutical/Biotechnology industry or equivalent experience preferred
- 3+ years of experience, ideally from a GCP Quality or Operational role within a Pharmaceutical, Biotech company or a CRO preferred
- Certified Quality Auditor Certification or equivalent experience preferred
- Experience drafting, editing, and reviewing GCP SOPs and WIs
- Experience maintaining a QMS for the management of controlled documents, training, deviation, CAPA and audit management is a strong plus
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!
eClinical is a winner of the 2023 Top Workplaces USA national award! We have also received numerous Culture Excellence Awards celebrating our exceptional company vision, values, and employee experience. See all the details here: https://topworkplaces.com/company/eclinical-solutions/
eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!
We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.
