Senior Associate - QA

IncepBio; Bengaluru; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

IncepBio in Bengaluru is seeking a Quality Assurance professional to develop and maintain QA policies, ensure GDP/GMP compliance, and oversee audits. You will manage documentation, SOPs, and reports, while training and mentoring team members.

The role requires collaboration with project managers, researchers, and external partners, plus supporting regulatory submissions, inspections, and client audits to uphold data integrity and quality standards.

Responsibilities

• 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.

Job description

• 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.