Clinical QA Audits Specialist
NC-RTP, US
 |
|
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. |
 |
Primary Responsibilities:
- Plan and conduct audits of CROs, vendors, clinical trial sites, and documentation associated with clinical trials. Assess compliance with applicable regulations and standards.
- Conduct internal audits of Clinical GCP processes for adherence to SOPs, company policy, and regulations/standards.
- Contribute to the review of the internal procedures related to the planning, conduct and oversight of clinical audits.
- Prepare audit reports and discuss findings with auditees and internal customers. Track and follow up on the resolution of audit findings.
- Provide guidance to Clinical staff in resolving audit findings in a compliant manner.
- Assist internal groups in preparing for inspections by regulatory agencies and participate in on site regulatory inspections as appropriate.
Requirements:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required.
- You have a Ph.D. Master, Bachelors in pharmaceuticals or life sciences related field.
- You have at least 3 years of practical experience in GCP and GCLP quality assurance or compliance.
- You are available to travel.
Location: NORTH AMERICA : EE.UU. : NC-RTP:USNC0001 - RTP NC-Headquarters