Experienced Quality Auditor with well-honed analytical skills with GCP and GCLP compliance auditing experience for five years. Solution-focused professional highly-regarded among peers and supervisors in diagnostic laboratories and clinical research industries. Skilled auditor who works diligently with all levels of peers, management and external authorities.
• Conduct audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines, and/or client contractual obligations
• Identify and address non-conformance issues, plan and deliver quality services for contracted audits.
• Prepare, schedule, perform GCLP audit of clinical laboratories.
• Present audit observations to internal project team
• Keep management (Audit Team Management) informed of potential compliance risks identified during audits.
• Submit audit report for QC and respond to comments/queries.
• Assist in the overall coordination of the laboratory audit report review functions Mentor new team members.
• Serves as a resource to operational departments on audit or quality assurance.
• Conduct orientation and training including accompanied field visits for new hires
• Prepare and develop GCLP course materials and deliver GCLP training.
• Assisted the laboratory manager to supervise and train staff in line with delegating responsibilities.
and deputizing requirements to reach work objectives.
• Ensured the implementation of service levels and quality standards in accordance with standard operating procedures.
• Assisted the lab manager with overseeing and monitoring equipment maintenance, asset.
management, and procurement of goods and staff overtime expenditure to ensure the most.
effective utilization of resources, optimization of stock levels and reduction of costs always
• Managed client liaison to maintain a positive image of the organization, promote the service and
monitor resolution of customer complaints
• Performed diagnostic testing procedures, reviews and verifies results and interacts with
pathologists on technical matters to provide all relevant results.
• Operated, maintained, and calibrated the equipment used in the laboratory to ensure that it is
operating efficiently and providing accurate results.
• Attended training and seminars and participates in continuing professional development (CPD)
activities
• Performed on-site training of laboratory staff, interns, students, medical colleagues and
associated health workers in laboratory techniques, processes, and systems.
• Adhered to professional conduct requirements in line with organizational Policy.
Training and coaching
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