BASIC SUMMARY:
Performs project and non-project quality assurance duties at PharPoint Research. Responsible for independently carrying out quality initiatives at the company, including but not limited to SOPs and training, computer systems validation, and Quality Management System.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Maintain the Quality Management System (QMS) consistent with current Good Clinical Practices (GCP), Good Documentation Practices (GDP) and other applicable regulatory and ethical requirements.
- Generate, review, and implement SOPs and associated training.
- Prepare, conduct, and follow up on vendor audits of current and potential vendors.
- Oversee the vendor audit program.
- Conduct internal audits.
- Conduct essential document audit s(e.g., TMF, CSR, etc.).
- Generate, approve, and implement external and internal audit plans and processes.
- Coordinate and host sponsor audits; coordinate and implement responses to audit observations.
- Support company regulatory agency inspections.
- Track GCP quality system metrics such as quality events, CAPAs, and deviations.
- Provide support and adhere to all aspects of PharPoint?s Quality System.
- Comply with PharPoint?s data integrity and business ethics requirements.
- Perform Quality Assurance Lead duties in support of computer system validation activities for the Company.
- Assist Department leadership with administrative and management functions as required.
- Perform all other related duties as assigned.
