Senior Associate - QA

IncepBio Private Limited; Bengaluru; On-site; INR 900,000 - 1,500,000; Full time

Job summary

IncepBio Private Limited is seeking a Quality Assurance professional to establish and maintain QA policies, ensure GDP/GMP compliance, and lead audits. The role includes guiding documentation, training, and helping drive CAPA across projects.

The position requires collaboration with research staff, vendors, and operations to uphold data integrity, risk management, and continuous improvement initiatives.

Qualifications

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.
• Ensure that all quality systems are validated and comply with data integrity requirements.

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.