This position provides support to the Research and Development for products being used in developmental studies. It supports responsibilities that Quality Assurance uses to monitor and document its activities through auditing, training, reviewing, and tracking study initiatives. This position will report to the Chief Development Officer. The position requires at least 5 years of experience in QA and auditing activities with respect to GXP Compliance. Knowledge and experience of Regulations pertaining to USA and EU a definite asset.
- Identify compliance issues and deviations from Health Authority Rules, Regulations, and Policies via auditing procedures with respect to GXP compliance within the organization and prepare SOP’s for such purposes as well as create SOP’s which are required for an expanding group especially in the area of CMC and Regulatory.
- Organize and carry out auditing activities and support developmental studies.
- Review and monitor corrective activities for such items.
- Prepare and carry out training sessions for R&D personnel in the areas of GxP
- Plan and oversee internal & external GCP audits; proactively identify quality issues/discrepancies, and effectively resolve them in a flexible, timely and constructive manner
- Lead risk and gap analyses; propose and lead corrective actions as required
- Resolve compliance issues at clinical sites and vendors; and provide assessment of the impact of potential deficiencies to the Chief Development Officer
- Contribute to GXP training efforts
- Ensure compliance of all development with all applicable regulations and standards
- Assist as and when required with respect to all aspects of Quality functions in the company.
- Maintain all documentation pertaining to Quality in a secure electronic and paper environment.
For more information, contact Jennifer Duncan at firstname.lastname@example.org.