Senior Associate - QA

Designation : Senior Associate - QA

Experience: 4 to 5 years

Location: JP Nagar, Bangalore (Onsite)

• 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.