Manager Quality Management System QMS

Agio Pharmaceuticals Limited; Pune District; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Agio Pharmaceuticals Limited in Pune, India, seeks a QA leader to drive the Quality Management System across sterile and non-sterile plants, ensuring compliance with ICH, cGMP and ISO standards. You will own Deviation, Non-Conformance, CAPA and Change Control processes, lead internal audits, and support regulatory inspections, with KPIs driving quality governance and continuous improvement.

This role requires strong documentation control, training program management, and proactive risk

Responsibilities

• Lead the development, implementation, and maintenance of the site's Quality Management System in accordance with ICH guidelines, cGMP regulations and relevant ISO standards.
• Ensure the QMS is comprehensive, well documented, and effectively deployed across all functions in the plant.
• Own and manage the overall Deviation and Non-Conformance process, ensuring timely investigation, root cause analysis (using tools like 5 Whys/Fishbone), and effective documentation.
• Oversee the Corrective and Preventive Action (CAPA) system, ensuring actions are relevant, effectively implemented, and verification of effectiveness (VoE) is performed.
• Manage the Change Control process, assessing the impact of proposed changes on product quality and regulatory status.
• Plan and execute the Internal Audit (Self-Inspection) program to monitor system compliance.
• Serve as a key resource during external regulatory inspections and customer audits, providing requested QMS documentation and leading follow-up on corrective actions.
• Define, monitor, and report Key Performance Indicators (KPIs) for all QMS processes (e.g., CAPA closure rate, deviation trends, training compliance) for management review.
• Prepare and lead the Management Review of the PQS to evaluate system effectiveness, align quality policies, and drive organizational quality objectives.
• Oversee the Document Control system, ensuring all documents (SOPs, protocols, policies, batch records) are controlled, current, and accessible.
• Develop and manage the quality Training Program, ensuring all personnel are adequately trained on cGMP, SOPs, and QMS principles.
• Facilitate the application of Quality Risk Management (QRM) principles across the organization to proactively identify, assess, and mitigate quality risks.

Job description

Key Responsibilities

For both Sterile & non-sterile plants.

QMS Strategy and Maintenance: Lead the development, implementation, and maintenance of the site's Quality Management System in accordance with ICH guidelines, cGMP regulations and relevant ISO standards.

Ensure the QMS is comprehensive, well documented, and effectively deployed across all functions in the plant.

Deviation, CAPA, and Change Control Management: Own and manage the overall Deviation and Non-Conformance process, ensuring timely investigation, root cause analysis (using tools like 5 Whys/Fishbone), and effective documentation. Oversee the Corrective and Preventive Action (CAPA) system, ensuring actions are relevant, effectively implemented, and verification of effectiveness (VoE) is performed. Manage the Change Control process, assessing the impact of proposed changes on product quality and regulatory status.

Audits and Inspections Readiness: Plan and execute the Internal Audit (Self-Inspection) program to monitor system compliance. Serve as a key resource during external regulatory inspections and customer audits, providing requested QMS documentation and leading follow-up on corrective actions.

Quality Metrics and Review: Define, monitor, and report Key Performance Indicators (KPIs) for all QMS processes (e.g., CAPA closure rate, deviation trends, training compliance) for management review. Prepare and lead the Management Review of the PQS to evaluate system effectiveness, align quality policies, and drive organizational quality objectives.

Documentation and Training: Oversee the Document Control system, ensuring all documents (SOPs, protocols, policies, batch records) are controlled, current, and accessible. Develop and manage the quality Training Program, ensuring all personnel are adequately trained on cGMP, SOPs, and QMS principles.

Risk Management: Facilitate the application of Quality Risk Management (QRM) principles across the organization to proactively identify, assess, and mitigate quality risks.