Support the auditing system lifecycle programs and processes across all Global QA business units.
• Maintains the QA database(s) ensuring Audits when identified are entered onto the system from audit plans/notification documentation and that the system is updated as required.
• Audit information is followed up as required, through the full audit life cycle including: Missing Information relating to the planned audits are identified, gathered and entered. Performed audits are confirmed. The full text of audit findings are entered onto the database from Sponsor/Regulatory audit reports. Follow-up of Reports and Corrective And Preventive Actions and Follow-up of overdue Critical/Major findings. Certificates and contracted audit documentation are issued and distributed as appropriate.
• Provide support to staff by answering more complex queries concerning the use of EDA
• Participate in systems validation process (such as User Acceptance Testing) as required
• Review and track documentation related to the Global QA auditing lifecycle (Internal, External
• Contracted customer audits regulatory inspections, and Regulatory Audits, Quality Issues, Corrective And Preventive Actions and status of Critical / Major issues)
• Maintains the system to track audit plans ensuring that signed audit plans are tracked, received and distributed
• Maintains the QA filing systems for audits including electronic filing of documentation and correspondence
• Produce documentation from the QA databases, including status reports of overdue information, tables and graphs, and reports illustrating overall trends for missing or overdue date entry requirements as required
• Use metrics to optimize performance, productivity, and effectiveness of the processes and systems
• Participate in the development and provide training on new/enhanced QA database maintenance processes including providing training to new users involved in QA database maintenance .Keep current in advances in area of expertise, including regulatory knowledge, trends, and developments, including complying with all required SOPs and timelines
• Following up and Closing audits/Inspection Corrective and preventive actions (CAPA) in the eQMS.
• Review and approval of Corrective and preventive actions (CAPA) and Effectiveness check (EC) plans
• Categorizing audit/Inspection findings in the eQMS
• High School Diploma or equivalent Req
• 5 years experience. Equivalent combination of education, training and experience.
• Proficient in Microsoft Office software, including Word and Excel.
• Proficient in electronic data management software.
• Ability to review, approve, and publish electronic records. Excellent English written and verbal communication skills.
• Positive interaction skills, attention to detail, and organizational skills.
• Ability to handle multiple tasks and to follow through with completion of assigned tasks with some supervision.
• Good problem solving skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and customers.
• Awareness of basic GxP requirements. Ability to learn scientific, medical, and regulatory terminology to gain an understanding of Quality data and fields in QA database(s) to be able to translate data user requests for information into specific queries required to independently generate requested metrics.
• May participate in audit conduct.
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