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Description
Job Title: Manager/Senior Manager QA Regulatory Affairs Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 8-15 years in Quality Assurance and Regulatory Affairs, specifically within the Vaccine, Injectable, and Sterile Industry Educational Qualification: M.Sc in Biotechnology, Microbiology, or a related field Bachelor’s or Master’s in Pharmacy Additional qualifications in life sciences or pharmaceutical sciences are a plus Job Overview: As the Manager/Senior Manager – QA Regulatory Affairs , you will play a pivotal role in ensuring that our vaccine , injectable , and sterile pharmaceutical products meet global regulatory requirements and quality assurance (QA) standards. You will oversee regulatory strategies, regulatory audits, and the management of Quality Management Systems (QMS) to ensure our products comply with industry-specific standards. This role demands extensive experience in regulatory affairs , particularly within the vaccine and sterile manufacturing domains, including handling CDSCO , EU GMP audits, and other regulatory matters. Key Responsibilities: Regulatory Strategy & Compliance: Develop and execute regulatory strategies to ensure compliance with global standards for vaccine , injectable , and sterile products . Maintain a strong understanding of global regulatory requirements, including FDA , EMA , WHO , and local regulations like CDSCO to guide product approvals and market entry. Ensure alignment of product development and manufacturing processes with Good Manufacturing Practices (GMP) , Good Laboratory Practices (GLP) , and other relevant GxP standards. Audit & Inspection Management: Coordinate and manage regulatory audits (e.g., CDSCO , EU GMP ) for vaccine , injectable , and sterile products, ensuring full compliance and readiness across all departments. Lead the preparation for regulatory inspections related to CDSCO and EU GMP , working closely with relevant teams to ensure effective corrective actions and continuous compliance. Manage responses to audit findings and ensure the implementation of corrective actions in line with industry standards. Quality Management System (QMS): Oversee the implementation and management of the Quality Management System (QMS) to ensure product quality and regulatory compliance. Lead the development and review of Standard Operating Procedures (SOPs) , ensuring that they align with current regulatory requirements for vaccine and sterile product manufacturing. Monitor and ensure compliance with the QMS framework across all departments to maintain consistent product quality. Regulatory Submissions & Documentation: Oversee the preparation, compilation, and submission of regulatory dossiers and eCTD documents to regulatory bodies (e.g., FDA , EMA , CDSCO ). Ensure that all required documentation and records are properly maintained and comply with regulatory standards, ensuring smooth regulatory approvals for vaccine , injectable , and sterile products . Risk Assessment & Mitigation: Conduct regulatory risk assessments to identify potential issues related to product development, manufacturing, and compliance. Develop and implement risk mitigation strategies to ensure uninterrupted production and compliance with regulatory standards. Cross-Functional Collaboration: Collaborate with internal teams such as R&D, Production, and Quality Control to ensure regulatory compliance throughout the product lifecycle, from development to post-market surveillance. Provide regulatory guidance and training to cross-functional teams, ensuring awareness of applicable QA practices and regulatory requirements . Corrective and Preventive Actions (CAPA): Lead the implementation of Corrective and Preventive Actions (CAPA) to address audit findings, non-conformities, and deviations, ensuring continuous improvement in compliance and quality practices. Key Skills and Competencies: Expert Knowledge of Regulatory Guidelines : Extensive knowledge of global regulatory requirements (e.g., FDA , EMA , WHO ) with specific expertise in vaccines , injectables , and sterile product manufacturing . Regulatory Submissions & Documentation Expertise : Strong experience in preparing regulatory dossiers and eCTD submissions in compliance with regulatory standards for vaccines and sterile products . Audit & Inspection Management : Hands-on experience managing CDSCO and EU GMP audits, including preparing for inspections, addressing findings, and implementing corrective actions. Quality Management System (QMS) Oversight : Expertise in implementing and maintaining QMS in compliance with GxP , FDA , EU , and WHO guidelines, ensuring product quality and regulatory compliance. Risk Management & Mitigation : Proven ability to conduct regulatory risk assessments and implement mitigation strategies to prevent non-compliance and product issues. Strong Leadership & Project Management : Demonstrated ability to lead cross-functional teams, manage multiple projects, and meet regulatory deadlines while ensuring alignment with quality and regulatory expectations. Corrective & Preventive Action (CAPA) Implementation : Experience in managing CAPA processes, addressing non-compliance issues, and ensuring the effective resolution of audit findings and regulatory observations. Excellent Communication Skills : Strong verbal and written communication skills, with the ability to liaise with internal teams, regulatory bodies, and external stakeholders in a professional and clear manner. About GreenSignal Bio Pharma Pvt Ltd: GreenSignal Bio Pharma Pvt Ltd is a leading pharmaceutical company specializing in vaccine , injectable , and sterile products . Our commitment to quality, compliance, and innovation has made us a trusted partner in the healthcare industry. We are looking for experienced professionals to contribute to advancing our vaccine and biologics portfolio while adhering to the highest regulatory standards. For more information, please visit: www.gsbpl.com How to Apply: Interested candidates can apply via email at: hr@gsbpl.com For inquiries, please contact us at: +91 8778926365 Join Our Team and make a significant impact in the vaccine and sterile product industries
