Quality Compliance Specialist
1 week ago
This position plays a vital role in ensuring quality and compliance within the organization. The successful candidate will provide support and oversight to quality personnel, focusing on audits and inspections.
Key ResponsibilitiesProvides monitoring and education to quality personnel for assigned quality system components, including audits and inspections.
Works closely with the process owner for continuous improvement of the process.
Serves as SharePoint Site Administrator for inspection management infrastructure development and management.
Facilitates and manages logistics for sponsor inspections and audits hosted by Medicines Quality Organization.
Manages data archiving and retrieval to support audits and inspections.
Performs timely data entry into Trackwise/OneQMS and maintains metrics for inspection readiness.
C coordiantes routine and ad-hoc mock inspections/rehearsals.
Maintains inspection readiness artifacts, including distribution lists, presentations, and training materials.
Participates in industry forums for inspection readiness information exchange and benchmarking.
Leads or conducts projects/tasks as requested for audit and inspection activities.
Responsible for compiling and reporting of audit/compliance metrics at appropriate levels for review.
Performs trend analysis on inspection issues/observations for governance meetings and ongoing inspection readiness.
Participates in annual audit and self-inspection plans preparation in collaboration with management and GQAAC.
Assists in Management Review preparations for audit and inspection data in collaboration with standard owners and GQAAC.
Bachelor's degree
Experience in Inspection/Audit preparation within a GCP/GLP/GPvP environment.
Knowledge of GLP, GCP, and GVP global regulations.
Excellent communication skills and ability to present information effectively.
Prioritize and handle multiple tasks with good planning and organization skills.
Work across functions to achieve results and apply judgment-based decision making.
5 years of experience in the Pharmaceutical Industry
Demonstrated ability to assess business operations and identify future state improvements.
Understanding of risk-based focus and prioritization based on Risk Management methodologies.
Ability to work independently and interact with various levels of management.
Limited travel: 0-10%
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