What are the responsibilities and job description for the Quality Assurance Lead position at RxCloud?
About Us
RxCloud is a leading organization in the biotech industry, dedicated to delivering high-quality services and products. We are committed to excellence and strive to make a positive impact in the lives of our customers and stakeholders. As a Gxp Auditor, you will play a critical role in ensuring that our operations meet the highest standards of quality and compliance.
Job Description
We are seeking a highly experienced Gxp Auditor to join our team. The successful candidate will be responsible for planning and conducting scheduled quality audits on behalf of RxCloud. This position will also act as a Subject Matter Expert (SME) for GxP auditing and quality projects. The ideal candidate will have a strong background in GxP auditing, regulatory compliance, and quality management systems.
Main Responsibilities
- Function as a Quality/GxP auditor of both external CDMOs and clinical sites, and internal laboratory operations.
- Develop and implement the global audit strategy, aligning with organizational goals and regulatory requirements.
- Perform audits across various departments and functional areas.
- Conduct risk assessments to identify potential areas of concern and develop appropriate audit plans and procedures.
Requirements
- Minimum bachelor's degree in any scientific discipline.
- A minimum of 20 years of relevant experience including 15 years of GxP auditing in a regulated environment focused on quality.
- Excellent knowledge of GxP regulatory requirements.
- Experience using electronic Quality Management Systems.
RxCloud is a leading organization in the biotech industry, dedicated to delivering high-quality services and products. We are committed to excellence and strive to make a positive impact in the lives of our customers and stakeholders. As a Gxp Auditor, you will play a critical role in ensuring that our operations meet the highest standards of quality and compliance.
Job Description
We are seeking a highly experienced Gxp Auditor to join our team. The successful candidate will be responsible for planning and conducting scheduled quality audits on behalf of RxCloud. This position will also act as a Subject Matter Expert (SME) for GxP auditing and quality projects. The ideal candidate will have a strong background in GxP auditing, regulatory compliance, and quality management systems.
Main Responsibilities
- Function as a Quality/GxP auditor of both external CDMOs and clinical sites, and internal laboratory operations.
- Develop and implement the global audit strategy, aligning with organizational goals and regulatory requirements.
- Perform audits across various departments and functional areas.
- Conduct risk assessments to identify potential areas of concern and develop appropriate audit plans and procedures.
Requirements
- Minimum bachelor's degree in any scientific discipline.
- A minimum of 20 years of relevant experience including 15 years of GxP auditing in a regulated environment focused on quality.
- Excellent knowledge of GxP regulatory requirements.
- Experience using electronic Quality Management Systems.
