To ensure compliance with Good Laboratory Practice (GLP) requirements, applicable regulatory guidelines, company SOPs, protocols, and quality systems. The role is responsible for monitoring GLP studies, conducting inspections, reviewing documentation and data, identifying compliance gaps, and supporting continuous improvement of the laboratory quality system.
Key Responsibilities
1. GLP Compliance
· Ensure laboratory activities are performed in accordance with applicable GLP guidelines and internal procedures.
· Monitor compliance with approved study protocols, SOPs, specifications and regulatory requirements.
· Support implementation and maintenance of the GLP quality management system.
· Identify GLP compliance gaps and recommend appropriate corrective and preventive actions.
1. Quality Assurance Activities
· Conduct routine, study-based and facility/process inspections.
· Review study protocols, amendments, raw data, reports and supporting documentation.
· Verify that deviations, incidents and non-conformances are properly documented and investigated.
· Track CAPA implementation and effectiveness.
· Support internal and external regulatory inspections and audits.
1. Documentation & Data Integrity
· Review laboratory records for completeness, accuracy, traceability and compliance.
· Ensure compliance with ALCOA+ data integrity principles.
· Review controlled documents, SOPs, forms, logbooks and records.
· Ensure appropriate handling, correction, retention and archiving of GLP records.
· Support review of electronic data, audit trails and computerized systems where applicable
1. Study/Project Support
· Support Study Directors and laboratory personnel in GLP-compliant study execution.
· Verify that qualified personnel, equipment, facilities and procedures are available before and during studies.
· Review study-related documentation and identify discrepancies.
· Ensure appropriate documentation of protocol deviations and unexpected events.
1. Training
· Conduct or support GLP awareness and compliance training.
· Maintain training records for relevant personnel.
· Identify training gaps and coordinate required refresher training.
1. Audit & Inspection Support
· Prepare documentation and records for client, internal and regulatory audits.
· Participate in audit/inspection responses and follow-up activities.
· Support preparation and implementation of remediation plans.
· Maintain audit and inspection records.
1. Equipment & Facility Compliance.
· Verify appropriate qualification, calibration, maintenance and use of laboratory equipment.
· Review relevant equipment records and logbooks.
· Support facility and environmental monitoring activities where applicable.
1. Reporting
· Prepare periodic GLP compliance reports and inspection reports.
· Escalate significant quality or compliance issues to management.
· Maintain trackers for deviations, CAPA, audits, inspections and training.
· Provide compliance status updates to management.
Benefits:
Work Location: In person
