- Develop and maintain QA policies and procedures.
- Ensure compliance with GDP, GMP, and other standards.
- Perform internal and external audits; drive corrective actions.
- Oversee documentation processes, including SOPs, protocols, and reports.
- Prepare and present quality reports to management.
- Create and deliver training programs on quality requirements.
- Mentor and coach team members.
- Collaborate with project managers, research staff, and external partners.
- Support regulatory submissions, inspections, and client audits.
- Analyse quality data to identify improvement opportunities.
- Lead and participate in continuous improvement projects.
- Identify and evaluate quality risks, implementing appropriate controls and mitigation strategies.
- Conduct risk assessments related to products, processes, and suppliers.
- Evaluate and monitor supplier quality, coordinating with procurement and other teams.
- Participate in vendor audits and follow up on corrective actions.
- Liaise with operation teams to ensure alignment of quality standards and testing procedures.
- Provide guidance on validation methodologies and equipment qualification.
- Lead or support change management activities related to quality systems and processes.
- Evaluate change proposals for potential quality impacts, ensuring proper implementation.
- Participate in service quality reviews, ensuring adherence to quality specifications.
- Investigate customer complaint, deviations & implementing necessary corrective and preventive actions.
- Ensure that all quality systems are validated and comply with data integrity requirements.
- Oversee the implementation and maintenance of quality-related software and technology tools.
- Ensure that all quality systems are validated and comply with data integrity requirements.