Responsibilities:

• Maintain the QA database, ensuring audits are entered onto the system from audit plans/notification documentation and that the system is updated as required
• Follow up on audit information throughout the full audit life cycle, including identifying missing information, confirming performed audits, and entering audit findings onto the database
• Provide support to staff by answering 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
• Maintain the system to track audit plans, ensuring signed audit plans are tracked, received, and distributed
• Maintain the QA filing systems for audits, including electronic filing of documentation and correspondence
• Produce documentation from the QA databases, including status reports, tables, and graphs
• 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
• 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
• Regular reporting on training & QA activities
• Training preparation, delivery, and assessment
• Provide real-time feedback, formulate action items, and refresher trainings based on QA assessments

Qualifications:

• 5 years of experience, or equivalent combination of education, training, and experience
• Proficient in Microsoft Office software, including Word, Excel, and PowerPoint
• Proficient in electronic data management software, EQMS in document management
• 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 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
• Amenable to work onsite in Mckinley Taguig and shifting schedule

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