Global R&D QA - Therapeutic Area Clinical Quality Assurance Auditors
Senior Associate/Senior Specialist (Level dependant on experience)
Global R&D Quality Assurance is looking to recruit a number of talented individuals as Clinical Quality Assurance (CQA) Auditors to work within the Therapeutic Area teams.
Description:
The role is responsible for the independent planning and conduct of audits of the clinical research activities of Pharma companies, business partners and vendors. These audits provide an independent quality assessment to ensure compliance with appropriate regulations, SOPs, processes, etc. as they pertain to company-sponsored research. Prepares and effectively communicates audit report findings. Conducts the critical review of documents, procedures, facilities, etc., to ensure accuracy for acceptance by International Regulatory Agencies. Serves as a consultant to the organization and associated Pharma companies on GCP matters. Assists with facilitation of inspections by regulatory authorities for Good Clinical Practice (GCP). Monitors new regulatory legislation or guidelines, which have direct impact on GCP regulatory compliance function.
Contributes to the assessment of current quality of clinical research activities & related systems and makes recommendations for improvement. Assists in process improvements and ongoing development of new auditing procedures, techniques and department guidelines. May participate in writing or revising TA CQA SOPs. May review and contribute to development and revision of other departmental SOPs. May attend project meetings
Routinely interacts with internal/external appropriate functional personnel in order to identify issues and recommend actions identified throughout the inspection/audit process. Takes action on solutions of moderate regulatory and technical complexity. Seeks supervisor's advice on issues of difficult complexity.
Monitors new regulatory legislation or guidelines, which have direct impact on regulatory compliance function and where appropriate, disseminates this information to members of other functional areas such as Regulatory Affairs, and Global Clinical Operations. The role also assists in the facilitation of inspections by regulatory authorities for GCP; both internal & site inspections.
Experience/Qualifications:
A Bachelor of Science (BSc) degree in a life science, natural science or computer science with experience in a specific compliance area and/or equivalent time and experience in a related R&D area is required.
Comprehensive knowledge in specific compliance discipline (GLP, GMP, GCP or Validation)
Comprehensive knowledge of the drug development process, regulation awareness and scientific terminology.
Understand preclinical/clinical systems or computer systems compliance documentation and regulatory records.
Knowledge of SOPs and documentation requirements in a regulated industry. Good oral and written communication skills, organized, detail oriented.
The successful candidate will have good direct QA or functionally related experience, or equivalent training is required.
Experience in either Virology or Neuroscience, CVS & Metabolism is also desirable.
Travel requirements:
Approximately 30-40%, both nationally and internationally. In times of temporary workload peaks this figure may be exceeded for a short period.
This job was posted 30+ days ago, and has expired.
