Quality Management System for Gene Therapy and Biological Products.

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 - ✔ Leading Site QA Team: Leading and supervising the Site QA Team, ensuring that all members are aligned with the organizational objectives and quality standards. Providing guidance, support, and mentorship to team members to foster a culture of excellence and continuous improvement. ✔ Managing People, Budget, and Driving Performance: Taking responsibility for managing the personnel within the QA department, including recruitment, training, performance evaluations, and career development. Effectively managing the budget allocated to the QA department, ensuring optimal utilization of resources while meeting quality objectives. ✔ Setting Departmental Plans and Priorities: Developing plans and setting clear priorities for the QA department in line with the overall organizational goals and objectives. Collaborating with senior management and stakeholders to ensure that QA plans are aligned with business priorities and strategies.✔ Building and Maintaining Department Competencies: Investing in the professional development of QA team members to enhance their expertise and capabilities in quality assurance activities. Providing ongoing training, coaching, and opportunities for skill development to ensure that the team remains up-to-date with industry best practices and regulatory requirements. ✔ Supporting Audits: Playing a key role in supporting internal, customer, and regulatory audits by providing necessary documentation, facilitating audit processes, and coordinating responses to audit findings. Collaborating with cross-functional teams to address audit observations and implement corrective and preventive actions (CAPAs) in a timely manner.✔ Implementing QMS and Ensuring Compliance: Taking a proactive approach to implementing and enforcing Quality Management Systems (QMS) across the organization, including affiliates and suppliers.

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 - ✔ Planned, Executed, and Scheduled Audits: Led the planning, execution, and scheduling of audits at all manufacturing sites of the organization and its subsidiaries. Ensured the availability of audit records in the electronic Quality Management System (eQMS) software for thorough documentation and tracking.✔ Development and Implementation of SOPs: Developed and implemented Standard Operating Procedures (SOPs) including Site Master File (SMF), Validation Master Plan (VMP), and Quality Manual. Conducted qualification or re-qualification audits of contract Clinical Research Organizations (CROs) to ensure adherence to quality standards.✔ Management of Quality Events: Demonstrated tenacity in managing deviations, change control proposals, non-conformances, incidents, Out of Specification (OOS) results, return/recalls, and market complaints. Led comprehensive root cause analysis, impact assessment, and Corrective and Preventive Action (CAPA) conformances to address issues effectively. ✔ Facilitation of Method Development and Validation: Oversaw method development and validation processes, ensuring rigorous testing to guarantee precision, accuracy, reproducibility, and specificity of methods tailored to product requirements.✔ Generation of Analytical Specifications: Generated analytical specifications for raw materials, intermediates, and finished goods in collaboration with analytical and regulatory teams. Focused on cost optimization through legitimate ingredient and process usage.✔ Analysis and Recommendation of Process Modifications: Analyzed various processes and applications, recommending modifications and equipment calibrations to enhance operational efficiency and ensure compliance with quality standards. ✔ Coordination of Product Development: Organized, planned, and coordinated entire product development processes, including requirement analysis, finalization of parts specifications, design, verification.

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 - ✔ Leadership in Quality Management System Execution: Provided leadership and support in executing the centralized Quality Management System at the site. Managed the end-to-end process for complaints management, Non-Conformance Reports (NCR) management, trainings, and change management, ensuring alignment with quality objectives. ✔ Supervision of Regulatory Notifications: Supervised the availability of inputs for higher management to ensure timely regulatory notifications, such as Changes Being Effected (CBE30), New Drug Application (NDA) Field Alert Reports, and market actions, facilitating compliance with regulatory requirements.✔ Achievement of Quality Targets: Ensured that all quality targets were achieved or exceeded for timely processing. Conducted audit readiness of quality management systems to maintain readiness for regulatory inspections and audits. ✔ Promotion of Process Alignment: Promoted alignment between regional and global processes, fostering collaboration with Medical Safety Organizations to investigate adverse events with potential product quality impacts. Contributed to enhancing process efficiency and effectiveness.✔ Audits and Vendor Qualification: Conducted audits and qualified raw material and packaging material vendors to ensure compliance with quality standards. Designed, implemented, and tracked activities related to Corrective and Preventive Actions (CAPA) to address quality issues. ✔ Root Cause Analysis: Performed activities related to investigations and root cause analysis for Out of Specification (OOS), Out of Trend (OOT), deviations, shopfloor observations, and Market Complaints. Utilized methodologies such as DMAIC and the six-step Root Cause Analysis (RCA) process to identify and address root causes effectively.

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 - ✔ End-to-End Complaint Management: Held accountable for driving the end-to-end process for complaint management in the Asia Pacific region. Ensured that the product quality complaint process was compliant, effective, efficient, and sustainable, contributing to customer satisfaction and regulatory compliance.✔ Monitoring Complaint Vigilance: Reviewed metrics and reports to monitor complaint vigilance, identify product trends, and promote continuous improvement initiatives. Analyzed data to identify areas for enhancement and implemented strategies to address emerging issues proactively.✔ Management of QMS Systems: Managed Quality Management Systems (QMS) processes such as Change Control, deviations/Non- Conformance Reports (NCRs), and Corrective and Preventive Actions (CAPA) through track-wise. Ensured compliance with regulatory requirements and internal quality standards.✔ Follow-Up and Tracking of Audit Reports: Conducted follow-ups and tracked audit reports through the Track-wise system. Monitored audit findings and implemented corrective actions to address identified gaps and improve overall quality performance.✔ Document Management: Managed document management processes through an automated Business Process and Lifecycle Management (BPLM) system. Ensured the accuracy, integrity, and accessibility of documentation to support regulatory complianceand operational efficiency.

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 - ✔ Leading a team of 12 Chemist, 15 IPQC persons & mentoring coaching them for GMP, IPQC & Hygiene.✔ Risk Assessment of various quality management systems and processes like change controls, Deviations etc.✔ Perform FMEA, HACCP, Root cause analysis and other process related investigation. Verification of CCPs & trends review of process.✔ Ensure timely internal & external calibration & preventive maintenance of all equipment in Labs.Equipment effectiveness post CIP, Personnel Hygiene and Air monitoring.✔ CAPA finalization in case of deviation, self inspection, internal audit, external audit & GQA audit.Lab 5S, GMP trainings & Documentation.✔ OOS Handling and investigation. ✔ To control the laboratory activity with a proper control of departmental employees to assure that laboratory personnel duties are complained.✔ Auditing & Qualification of third party product testing laboratories.✔ Selection, qualification & approval of vendors of both packing material & raw materials.✔ Reviews all complaints received from consumers & customers with proper investigation & where emphasis should be placed at the plant to resolve specific quality problems and to prevent recurrence by driving QIP"s by coordinating with manufacturing team.✔ To assist in development of new artworks & packing materials as continuous improvement program. Providing feedback on material quality to the local supply management team in connection with the purchase of raw/ packing materials and supplies.✔ Ensures compliance with applicable laws and regulation and product quality standards issued by local regulatory agencies (FDA)).✔ Maintains satisfaction as to quality through internal and external inspection services of raw/ packaging materials, finished goods, and production operation and processes.

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝐲 - ✔ Process validation of products, Stability studies, Risk Assessment of various quality management systems and processes like change controls, Deviations etc., Preparation of Cleaning validation master plan and Cleaning validation of equipments and facility.