We are looking for a seasoned Quality Assurance Head to champion quality and compliance at Reputed Pharmaceutical Company, ensuring the highest standards in pharmaceutical manufacturing. As QA Head, you will spearhead the establishment and maintenance of robust Quality Management Systems (QMS) aligned with global regulatory standards (EU GMP, US FDA, MHRA, WHO). Your leadership will be pivotal in managing internal and external audits, driving CAPA implementation, and overseeing deviation investigations to maintain product integrity. The ideal candidate will possess a deep understanding of cGMP, ICH guidelines, and QbD principles, coupled with exceptional leadership and communication skills. You will play a critical role in ensuring regulatory compliance, managing supplier quality, and fostering a culture of continuous improvement within the QA team. You will ensure compliance with cGMP, GLP, GDP guidelines, batch release and documentation, and also lead regulatory inspections. If you are passionate about quality, possess a strategic mindset, and thrive in a dynamic pharmaceutical environment, we encourage you to apply and lead Evertogen towards excellence in quality assurance. Job Details: Industry: Pharmaceutical Department: Quality Assurance Role: Quality Assurance Head Location: Jadcherla Compensation: Up to 30,00,000/Annum Experience: Above 15 Years Employment Type: Full-time Qualification: Bachelor's/ Master's in Pharmacy or Chemistry Responsibilities: Quality Systems & Compliance Establish, implement, and maintain a robust Quality Management System (QMS) compliant with EU GMP, US FDA, MHRA, WHO, and other relevant regulatory requirements. Oversee the development, review, and approval of Standard Operating Procedures (SOPs) and other quality-related documentation. Lead and manage internal audits to assess compliance with cGMP guidelines and identify areas for improvement. Ensure adherence to data integrity principles and practices across all quality-related activities. Represent the company during regulatory inspections and customer audits, ensuring effective communication and resolution of findings. Monitor and report on key quality metrics, identifying trends and implementing corrective actions as needed. Batch Release & Documentation Review and approve Master Batch Records (MBRs), Batch Manufacturing Records (BMRs), and Batch Packaging Records (BPRs) to ensure accuracy and completeness. Oversee the timely release of batches, ensuring compliance with all applicable regulatory requirements and quality standards. Manage the documentation control system, ensuring proper storage, retrieval, and archival of quality records. Ensure all documentation is in compliance with cGMP principles and regulatory guidelines. Collaborate with production and other departments to resolve any issues related to batch documentation or release. Implement and maintain systems to track and trend batch release metrics, identifying areas for improvement. Deviation, CAPA & Change Control Lead investigations into deviations, out-of-specification (OOS) results, and out-of-trend (OOT) results, identifying root causes and implementing corrective actions. Manage the Corrective and Preventive Action (CAPA) system, ensuring timely and effective resolution of quality issues. Review and approve change control requests, assessing the potential impact on product quality and regulatory compliance. Monitor the effectiveness of CAPA plans and change control implementations, ensuring that they achieve the desired results. Collaborate with cross-functional teams to identify and implement preventive actions to minimize the risk of future deviations. Ensure all deviations, CAPAs, and change controls are documented and tracked in accordance with company procedures. Regulatory & Customer Audits Serve as the primary point of contact for regulatory agencies during inspections, managing the audit process and responding to inquiries. Lead the preparation for and conduct of customer audits, ensuring compliance with client requirements and expectations. Review and approve responses to regulatory observations, audit findings, and market complaints, ensuring timely and effective resolution. Maintain up-to-date knowledge of regulatory requirements and industry best practices, ensuring that the company remains in compliance. Develop and implement strategies to improve the company's audit readiness and overall compliance posture. Establish and maintain strong relationships with regulatory agencies and customers. Supplier & Vendor Qualification Oversee the vendor qualification program, ensuring that all suppliers of raw materials, packaging materials, and contract services meet the company's quality standards. Conduct audits of suppliers and vendors, assessing their compliance with cGMP guidelines and other regulatory requirements. Review and approve supplier quality agreements, ensuring that roles and responsibilities are clearly defined. Monitor supplier performance, identifying and addressing any quality issues or concerns. Collaborate with procurement and other departments to ensure that supplier quality is a key factor in sourcing decisions. Maintain a list of approved suppliers and vendors, ensuring that all are qualified and meet the company's standards. Training & Team Management Develop and implement training programs for QA, production, and other relevant departments on cGMP, data integrity, and regulatory requirements. Lead, mentor, and develop a high-performing QA team, fostering a culture of continuous improvement and collaboration. Conduct performance reviews and provide feedback to team members, identifying areas for development and growth. Ensure that all QA personnel are properly trained and qualified to perform their assigned duties. Promote a culture of quality and compliance throughout the organization. Manage the QA budget, ensuring that resources are allocated effectively to support the company's quality goals. General Expectations and Past Experiences: Possess a Bachelor's or Master's degree in Pharmacy, Chemistry, or a related scientific field. Demonstrate 15+ years of progressive experience in Quality Assurance within the pharmaceutical industry, with a focus on sterile dosage forms. Exhibit in-depth knowledge of cGMP regulations, ICH guidelines, and global regulatory requirements (US FDA, EU GMP, MHRA, WHO). Proven ability to lead and manage a QA team, fostering a culture of collaboration, accountability, and continuous improvement. Expertise in conducting and managing regulatory inspections and customer audits. Proficiency in Quality Risk Management and the application of QbD principles. Strong problem-solving and decision-making skills, with the ability to analyze complex situations and implement effective solutions.
