Clintec is actively recruiting for a Quality Assurance Auditor (GCPxPV) to join our expanding global company in Glasgow on a permanent contract. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.
The Auditor will provide Clinical Quality Assurance support and services for Clintec Operations to ensure regulatory compliance and adherence to company procedures.
Responsibilities of the Auditor:
Undertake GCP/ PV compliance audits in all areas of clinical operations.
Conduct vendor audits and qualification assessments.
Plan, undertake and document study audits to verify the integrity of the data and determine whether studies are undertaken in compliance with GCP/ PV, legislation, industry guidelines, protocol and procedures.
Assist in preparation and facilitation of sponsor audits and GCP/ PV regulatory inspections.
Undertake system audits and document specific audits to determine whether procedures and systems are adequate, relevant to current operational practices and compliant with SOPs.
Identify any procedures that are not consistent with GCP/PV, regulatory requirements or applicable guidelines.
Support the QA function in the effective planning, scheduling and resourcing of GCP/PV activities.
To provide quality representation on Clintec project teams.
To deliver regulatory training as required and provide on-going quality updates to relevant company and vendor personnel as required.
To provide a consultation, advisory role for any GCP/PV issue that arise from within Clintec
To provide regular updates to Clintec operations on quality activities and advise on approaches to meeting future GCP/PV/Regulatory requirements.
Provide support for to Head of Quality Assurance in business development
Bachelor’s degree, in a Scientific or health care discipline;
Knowledge and experience in GCP/ PV auditing
Knowledge of PV regulations
Proficiency in ICH GCP Guidelines and regulatory requirements for the conduct of clinical trials;
Understanding of the drug development process
Possess good verbal and written communication skills with basic scientific vocabulary, interpersonal skills and excellent organisational skills.
The ability to work well independently and as a part of a team with people at all levels within Clintec is essential.
The ability to multi-task, troubleshoot, problem solve, research, and make sound decisions based on scientific evidence and regulatory requirements is a must.
Willingness to travel
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.