Gcp Compliance
2 weeks ago
Overview:
RTI Health Solutions (RTI-HS), a business unit of RTI International, is an independent and internationally recognized research organization. We provide healthcare consulting and research expertise to optimize decision-making for pharmaceutical, biotechnology, and medical device products across the development and marketing life cycle. Clients rely on our expertise, quality standards, and integrity to guide their product development and regulatory and market access strategies. Our service groupings include Value, Access, and HEOR; Patient-Centered and Outcomes Research; Epidemiology and Biostatistics; Medical Communications; Global Business Operations; and Strategic Consulting and Growth. RTI-HS has office locations in the US, UK, Spain, France, and Sweden.
We are currently seeking a Quality Assurance Auditor to provide oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines
In this role, you will provide expertise and guidance in interpreting policies, regulations, and agency guidelines to ensure compliance. Working closely with operating entities, you will analyze processes, enforce requirements, and ensure adherence to applicable guidelines. You will also lead audit and inspection preparation, manage the resolution of findings, and serve as the primary liaison with auditing groups and inspectors throughout all audit stages.
Additionally, you will oversee the maintenance and regular updates of quality assurance programs and policies to align with evolving standards. You will implement uniform standards across global operations, promoting the sharing of best practices to advance the company’s mission. Key responsibilities include conducting internal audits of non-interventional and observational research processes, offering project support, and reviewing project-related documents to uphold compliance and quality. You will also manage corrective and preventive actions to address identified issues and maintain accurate, up-to-date audit documentation
**Responsibilities**:
**Additional responsibilities will include but not be limited to**:
- Recognises the need for, organises, and conducts training programs.
- Keeps current on regulations and guidance.
- Evaluates compliance with all of RTI, all applicable regulations, project policies and procedures.
- Reviews and writes standard operating procedures and QA policies, procedures, and related documents.
- Writes audit plans and audit reports.
- Conducts audits and inspections of GCP, non-interventional/observational research projects, and non-regulated documentation.
- Tracks and reviews proposals.
- Reviews and audits validated systems.
**To be successful in this role, you will demonstrate the following attributes**:
- Ability to prioritise multiple tasks.
- Ability to work well with others.
- Ability to listen and communicate well both verbally and in writing.
- Ability to work independently and as part of a team.
- Attention to detail and accuracy.
Qualifications:
- Bachelor's Degree and 5 years of related experience
- Experience with GCP audits and regulatory inspections.
- Non-interventional/observational research experience.
- Excellent knowledge of MS Word, Outlook, PowerPoint, Excel.
**Preferred**:
- Quality Auditor Certification desirable.
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