ICON plc, a globally recognized leader in healthcare intelligence and clinical research, invites passionate professionals to join its esteemed team as a Quality Assurance Auditor I. With a focus on innovation, diversity, and excellence, ICON is committed to shaping the future of clinical development while nurturing its employees’ growth and well-being.
This role offers the flexibility of remote or hybrid work, allowing candidates to contribute effectively from Bangalore, Chennai, or a combination of office and remote settings.
About ICON plc
ICON plc is a top-tier organization dedicated to advancing healthcare through cutting-edge research and technology. By fostering an inclusive culture, ICON continues to push the boundaries of clinical development, ensuring excellence in every aspect of its operations.
Responsibilities in the Role
As a Quality Assurance Auditor I, you will play a pivotal role in ensuring the highest quality standards in clinical trial activities. Your responsibilities will include:
- Quality Assurance Processes: Assisting in the creation and implementation of QA processes to support clinical trials.
- Routine Assessments: Conducting audits to ensure adherence to regulatory standards and guidelines.
- Collaboration: Partnering with project teams to identify quality issues and implement corrective actions.
- Documentation Review: Reviewing and approving documentation related to clinical trial operations and quality management systems.
- Record Maintenance: Contributing to the upkeep of quality assurance documentation and records.
Qualifications for the Role
To thrive in this role, candidates should possess:
- A Bachelor’s degree in Life Sciences, Pharmacy, or a related field (advanced degrees are a plus).
- Previous experience in QA within the pharmaceutical, biotechnology, or CRO industry (preferred but not mandatory).
- Basic knowledge of regulatory requirements for clinical trials (e.g., ICH-GCP, FDA regulations).
- Exceptional attention to detail and organizational abilities.
- Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
Key Skills Required
- Familiarity with GxP Risk Impact Assessments and Validation Reviews.
- Understanding of computerized system validation (CSV) and vendor qualification.
- Knowledge of operational areas such as IRT, Medical Imaging, and Clinical Trials.
- Ability to prioritize tasks and manage multiple responsibilities.
