
Clinical Quality Assurance Specialist
3 days ago
About Us:
Santen Pharmaceutical Co. is a dedicated company to eye health, aiming to contribute to the realization of 'Happiness with Vision' by providing valuable products and services to patients, consumers, and medical professionals around the organization.
Job Description:This role will provide direct support to the Head of Global Clinical Quality (CQA) and Pharmacovigilance Quality Assurance in managing compliance related to cGCP, pharmacovigilance, and other related activities.
Key Responsibilities:
- Support continuous improvement of quality processes and systems that ensure compliance with clinical study-related activities in collaboration with contract research organizations and in-house clinical development.
- Design Clinical QA folders for all development studies that are easy to navigate and identify.
- Support preparations for and follow-up of effective audits of investigator sites, essential documents, Trial Master Files, vendors, and internal processes.
- Provide effective oversight of systems cross-functionally in clinical research and development in collaboration with matrix team members.
- Ability to identify, evaluate, and communicate risks to Clinical Quality Assurance processes and/or systems with recommendations for resolution.
- Support training staff and external partners in compliance, current clinical practices, and procedures.
- 6+ years of experience in Clinical Quality Assurance, Quality Assurance, or Clinical Operations within Pharma or Biotechnology industry.
- Broad knowledge of risk-based quality systems consistent with Good Clinical Practice.
- Attention to detail as well as crisp, clear and concise style in written and oral communications.
- Demonstrated ability to work independently and flexibly in a fast-paced, high-growth environment.
- Bachelor's degree in a scientific field.
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