QA APR and Trending Associate

Job Responsibilities

Quality Council

• Develop, update, implement, and/or maintain Key Performance Indicators (KPIs) to track and monitor key metrics related to quality, compliance, operations, and overall system health. Adjust KPIs based on evolving business needs and regulatory changes.
• Work with internal teams to ensure the alignment of KPIs with business goals and regulatory requirements.
• Collaborate with cross-functional teams to ensure data integrity, consistency, and best practices are maintained across systems and reporting processes.
• Gather/collect, review, and conduct detailed data analysis to identify negative trends, root causes, and areas for improvement across KPI metrics. Use statistical tools and techniques to analyze datasets and extract meaningful insights. Ensure the metrics and tools align with regulatory requirements and GMP standards, contributing to the ongoing compliance of the organization's operations.
• Identify and monitor negative trends in quality metrics, production performance, compliance, and other critical systems.
• Collaborate with cross-functional teams to identify process improvements, optimizations and/or opportunities for system enhancements to ensure sustained high-quality performance.
• Prepare presentations and reports using data visualizations and dashboards to effectively communicate findings, trends, and recommendations to stakeholders at all levels of the organization.
• Lead discussions and reviews with stakeholders to drive data-driven decision-making and continuous improvement initiatives.

Annual Product Review

• Lead the planning, preparation, and execution of Annual Product Reviews (APRs) for all marketed products in compliance with the applicable regulatory requirements (e.g., FDA).
• Gather, coordinate and collaborate with cross-functional teams to compile relevant data and insights for the APR process. Analyse data related to product performance, manufacturing processes, and compliance metrics to ensure a comprehensive review and assess the quality performance over the product lifecycle.
• Identify and assess any negative trends, emerging risks and/or opportunities for continuous improvement related to product quality, compliance, or operational performance within the product lifecycle and manufacturing processes based on the data collected and APR findings.
• Perform root cause analysis for any identified trends and propose corrective and preventive actions (CAPA), as applicable. Collaborate with relevant departments to implement corrective and preventive actions, process optimizations, and improvements in quality systems. Monitor the effectiveness of implemented corrective actions.
• Ensure the APR reports comply with regulatory guidelines and accurately reflect the overall product quality, compliance, and performance trends.
• Document any conclusions, actions taken, and recommendations resulting from the APR.
• Prepare detailed APR reports, summarizing key findings, product performance metrics, and areas of concern and/or opportunities for senior management, clients and regulatory bodies.

Trend Reports

• Perform statistical analysing of product, process, and performance data; assess trends to identify issues, patterns, and values that inform the establishment of control limits, drive continuous improvement, and support data-driven decision-making.
• Performs complaints trending on a quarterly basis and deviation trending as required by established procedures and/or business needs.

General

• Support continuous improvement efforts through data analysis and identifying trends that impact performance.
• Provide necessary support during internal/external audits and regulatory inspections, including provision of requested documentation.
• Writes/revises SOPs and/or Work Instructions (WI) relevant to the position's responsibilities.
• Investigate root causes and implement corrective and preventive actions (CAPA), as necessary.
• Ensures process compliance with regulatory requirements and guidelines (i.e. FDA, and other applicable regulations), GMPs, company policies and procedures.
• Stay current regulatory requirements related to APRs and adapt the internal process as needed.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements. Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
• Performs special projects and/or other relevant duties as directed by management.

Qualifications: Education/Experience

• Bachelor's degree in Life Sciences, Engineering, Data Analytics, Statistics, or a related field.
• At least 3-5 years of experience in data analysis, metrics, and reporting within a GMP-regulated pharmaceutical or healthcare environment.

Knowledge, Skills and Abilities

• Strong understanding of quality systems, regulatory compliance, and GMP standards.
• Proficient in Microsoft Office Suite (Excel, PowerPoint, Word) and data analysis tools.
• Strong analytical skills with the ability to interpret complex data and trends.
• Excellent communication skills with the ability to present data findings to senior management and cross-functional teams.
• Detail-oriented with a proactive approach to identifying and addressing potential issues.
• Knowledge of quality management systems (QMS), and root cause analysis methodologies.
• Ability to work effectively in a fast-paced, cross-functional team environment.
• Strong problem-solving and critical-thinking skills.
• Strong organizational and time management skills.