Our leading Pharmaceutical client is looking for a GCP Specialist to join their team.
The main role job is to carry out and adopt the Global Quality Plan, to assist the assigned business line staff in improving compliance with ICH /GCP - SOP's, applicable regulatory requirements and guidelines. Contribute to the development and be responsible for the implementation of specific quality improvement initiatives as agreed with the Heads of Quality Management and the relevant Head(s) of assigned business line. Provide advice and support to relevant key stakeholders with regards to quality control, risk assessment, risk management and corrective/preventive actions. Contribute to the development and be responsible for the implementation of specific quality improvement initiatives as agreed with the Heads of Quality Management and the relevant Head(s) of assigned business line. Provide advice and support to relevant key stakeholders with regards to quality control, risk assessment, risk management and corrective/preventive actions.
Adopt and implement the Global Quality Management Plan within the scope of the assignment; this will include:
Planning and executing the Quality Management activities;
Risk identification and assessment through data review and quality control processes either remote or on site;
Providing support in risk mitigation, in planning corrective/preventive actions and guidance for improvement;
Supporting the assigned business line management and staff to enhance effectiveness of Site Visits conducted by them.
Cooperate closely with the relevant Heads of business and other stakeholders, support maintaining focus on quality in project delivery. Contribute to the development and implementation of a Regional/Delivery Unit/Sponsor specific Quality Management Plan and Risk Management Program, monitor the implementation and delivery.
Provide advice and support
Work in close cooperation with operational teams
Strong working knowledge of medical terminology, clinical monitoring procedures (SOPs), ICH-GCP, applicable regulatory requirements, quality management processes
Knowledge of National and International Regulations and Drug Development processes
Strong computer skills including Microsoft Office and Clinical Trial Management System (CTMS) applications
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in life sciences or equivalent nursing qualification with a minimum of 5 years’ experience in Clinical Monitoring including at least 2 years’ experience in a role equivalent to a Clinical Project Manager/Clinical Team Lead