R&D QA Auditor SpecialistApply Now

Category: Quality Assurance
Location: RTPNC
Salary: TBD

Job Description:

RESPONSIBILITIES:
To assure the compliance and the correct application of Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP) inside the clinical development of the R&D projects in FDA environment.
DESCRIPTION OF THE ACTIVITIES:
 Execution of first party audits inside R&D.
 Execution of second party audits to Clinical Research Organisations (CRO), Clinical Laboratories, Trial Master Files, investigational sites, suppliers supporting clinical trials under FDA requirements.
 Finalisation of audit reports following first and second party audits
 Support to R&D Departments involved in the management of findings (non-conformities) coming from first and second party audits
 Assessment of Requests for Information of Clinical Research Organisation (CRO), clinical laboratories, clinical suppliers as per clinical providers qualification process and maintenance of their quality status.
 Finalisation of Quality Agreements with clinical providers
 Support the responsible of the Unit in collecting information supporting the preparation of the audit programme for GCP and GCLP auditing activities
 Support the monitoring and the updating of the audit programme for GCP and GCLP auditing activities
 Support the monitoring of the “Preventive Actions “in R&D.
 Collect data for the “Management Review “and for KPIs.
 Collect quality data inside R&D Quality Assurance for the quality evaluations and metrics
 Finalisation/review of SOPs relating to GCP-GCLP auditing activities.
 Organisation of training on GCP-GCLP regulations/procedures under FDA requirements


Job Requirements:

DEGREE
Scientific Degree
REQUESTED EXPERIENCE
 At least three years as GCP-GCLP auditors in pharmaceutical companies or Contract Research Organisation (CRO)
 At least three years in clinical trials management on investigational medicinal products and/or medical device as Clinical Research Associate (CRA) or Clinical Project Manager (CPM) in pharmaceutical companies or Contract Research Organisation (CRO)
 ISO auditor Certification
TECHNICAL SKILLS
 Knowledge of GCP-GCLP requisites under FDA requirements
 Knowledge of auditing technique
 Knowledge of training technique
 Knowledge of the pharmaceutical development process, in specific of the clinical development phases and management of the investigational medicinal product in clinical trials
MANAGEMENT SKILLS
Leadership, Organisational skill, Stress management, Independent judgement and objectivity, Team working, Networking, Decision making, Ability in listening, Orientation to efficiency
INFORMATIC SKILS
Ability with the principal informatic system (Word, Excel, Outlook, PowerPoint), ability with Trackwsie for the management of the audit and findings (non-conformities) from audits

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