Chief Quality Systems Manager

The Head of Quality Assurance is a critical leadership position responsible for overseeing the development and implementation of quality systems, ensuring compliance with regulatory requirements, and driving continuous improvement within the organization.

Key Responsibilities:

• Develop, implement, maintain, and improve Quality audit and GMP quality systems
• Coordinate and perform all vendor qualification activities for Raw Materials, Packing Materials, Quality Control external testing Laboratories, and any other outsourced activities
• Responsible for coordination and finalization for Qualified Person audits and Regulatory Inspections
• Responsible for CAPA close out for all audits and inspections
• Develop, maintain, and improve a GMP compliant document control system
• Establish a robust Quality Management System (QMS) to manage and implement change management, Deviation management, Incidents, complaint handling, and CAPA management
• Responsible for All GMP trainings and Quality training programme
• Oversee investigations of all non-conformances (deviations, complaint etc.)
• Responsible for handling Product Recall
• Create and maintain system to implement requirements of ICH Q8 (QBD), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System)
• Ensure that cGMP requirements and quality standards are recognized, understood, and maintained across the Company
• Work across all disciplines (e.g. manufacturing, warehouse & QC, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies
• Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes
• Lead, manage, and ensure proper training to any relevant change management programs throughout the company
• Provide quality guidance to product development projects and programs
• Responsible for Data Integrity Internal Audits, Training, and Review and Reporting to the management
• Ensure all validation activities (process/cleaning/method/equipment etc.) are carried according to approved protocols and requirements
• Well-versed with requirements of Injectable products, facility requirements, and Media fill requirements
• Responsible for Technology Transfer documents compile necessary records and smooth transmission to meet and comply to regulatory requirements
• Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time, and cost
• Ensure development of departmental SOPs (writing, revising, and approving), ensuring regulatory compliance in conjunction with being - fit for purpose operationally and commercially
• Ensure that all activities are performed in accordance with GMP, company SOPs, and Health and Safety policies
• Ensure that there is a self-inspection programme in place to meet the requirements of EU GMP/PICS/TG/MHRA etc.
• Responsible for OOS and OOT
• Organize review meeting and document their actions and corrective measures implemented for cGMP requirements
• Monitor the IPQA activities, review, and report
• Responsible and nominated by management as cGMP administrator
• Responsible for Preparation, Review, Finalization, and time-to-time submission of documents if any to external customers and Agencies as per Regulatory Requirements
• Adherence to the Validation master plan and adherence to the Validation schedule
• Control Sample Management (Final Retention Samples) along with QC
• Stability Management along with QC team
• Responsible for Quality Review Meetings and Management Review Meetings
• Documentation cell and Lifetime documents archival Programme
• Artwork Approval and Shade card maintenance
• Label management and Risk Management
• Shredding and Maintenance
• Review of all Layouts along with Engineering Team
• Review of Pest Control management, Fire Extinguisher Annual documents along with EHS, HR, and Engineering Team
• Review and Finalization of water system validation documents along with Engineering department
• Conducting Transport validation, Review, and finalize the protocol/Reports
• National and International Manufacturing Licencing activities along with Regulatory Affairs team for the Site and Archival
• Quality Agreements and Vendor Agreements and adherence
• All dispatches of Finished Products as per country specific approvals],