- Develop a comprehensive set of quality metrics aligned with organizational goals and industry standards. This involves collaborating with stakeholders to identify key performance indications (KPIs) and defining measurable objectives.
- Collaborating with cross functional client Quality and other PSS site team.
- Collecting data from various process areas, defect reports and performance metrics. Analyze the data to identify trends, patterns, and areas of improvement.
- Generate regular investigation, training reports to provide visibility into quality performance. Manage quality improvement activities, meetings and other activities supporting the work of the departments.
- Presenting and Communicate quality related metrics, trends, and insights to stakeholders at various level of the organization. Present findings in meetings, reviews, and reports to facilitate informed decision making.
- Evaluate and managing resources and task- understanding department needs to evaluate resources needed by implementing the Capacity model system and cross-functional training.
- Work in a GMP-regulated environment to provide and assist in the implementation of quality-related activities.
- Assist with other aspects of quality improvement including administrative and operational support as needed.
- Drive continuous improvement efforts through monitoring/evaluation of site systems & processes aligned with GMP and FDA requirements. To ensure adherence with quality standards and best practices.
- Evaluate the thoroughness and effectiveness of the training program. Foster a culture of quality awareness and continues improvement throughout the organization.
- Provide oversight of systems to ensure compliance with internal policies, procedures, and guidelines.
QA Essential Duties and Responsibilities:
- Applies GMP/GLP in all areas of responsibility, as appropriate
- Demonstrates and promotes the company's vision
- Regular attendance and punctuality
- Ensure that the quality policy program is understood, implemented, and maintained at all levels of the organization; identify, prevent, or correct any departures from the quality system
- Coordinate workflow and perform daily monitoring to meet TAT
- Perform and/or assign other duties as requested to ensure the smooth operations of department