Support the development and maintenance of Quality Management Systems, conducting audits, and providing training to ensure quality assurance in clinical research.
Responsible to support the development, implementation, maintenance, and monitoring of Quality Management Systems (QMS) and activities in the execution of Quality Assurance Deliverables. Responsible for supporting the business in Quality Assurance, through audit activities in support of ongoing quality improvement. Acts as a liaison with other business units and partners and assumes some responsibilities for Quality led initiatives, based upon knowledge of regulations, standards, and industry best practices.
Quality Assurance Implementation (70-75%)
- Executes assigned actions related to the corporate Quality Plan.
- Provides guidance to eQMS modules users.
- Reviews and approves document change requests and CAPAs submitted by internal stakeholders.
- Liaises with internal stakeholders to facilitate the development/revision and review of QMS documents (SOPs, Work Instructions, Associated Documents), Root Cause Analysis/CAPAs and training materials as required.
- Leads improvement initiatives for quality processes against corporate standards and regulatory requirements.
- Supports audits (internal, site, vendor) and associated Corrective Action and Preventive Actions (CAPA’s).
- Provides guidance, as required, to internal stakeholders related to the interpretation of GCP and regulatory requirements.
Regulatory, Ethical Conduct and Audit Monitoring (10-15%)
- Remains current on and communicates changes to relevant regulatory requirements and industry standards.
- Assists in the identification of process changes to QMS documents and/or training requirements to meet regulations, standards, and sponsor expectations.
- Supports Sponsor and regulatory inspections or audit activities.
Quality Assurance Training
- Identifies, creates, adapts, and delivers quality assurance orientation as well as department, project team and clinical site quality assurance training programs.
- Initiates training plan creation and manages the training database.
- Liaises with Human Resources to communicate training assignments.
Qualifications
- The successful candidate will possess either an undergraduate degree with 1-3 years of related experience and on the go training, or a College Diploma with 4-6 years of related experience and training.
- Clinical Research, Quality Assurance or Information Technology experience preferred. Analytical, critical thinking, problem solving and attention to detail skills required. Strong computer skills required. Basic knowledge of ICH GCP and global regulations governing Clinical Research.
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Top Skills
Capa
Eqms
GCP
Quality Management Systems
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