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.