Quality Head

Job Responsibilities: QA Head (Regulatory Parenteral Pharmaceuticals Plant)

• Lead and oversee the Quality Assurance (QA) function in compliance with national and international regulatory guidelines such as USFDA, MHRA, EU-GMP, WHO-GMP, and other regulatory bodies.
• Develop, implement, and maintain the Quality Management System (QMS) to ensure adherence to current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).
• Ensure the timely review and approval of batch manufacturing records (BMRs) and batch release processes.
• Prepare for and manage regulatory inspections and audits conducted by authorities such as USFDA, MHRA, WHO-GMP, and other agencies.
• Coordinate and ensure timely responses to audit observations and oversee the implementation of corrective and preventive actions (CAPA).
• Ensure the plant's compliance with all applicable regulatory requirements and maintain required certifications.
• Ensure proper validation and qualification of critical equipment, utilities, and processes, including media fill validation and sterilization validation.
• Approve and oversee process validation, cleaning validation, and analytical method validation activities.
• Supervise the preparation, review, and approval of Standard Operating Procedures (SOPs), protocols, reports, and other quality-related documentation.
• Implement and manage change control processes to assess the impact of changes on product quality and regulatory compliance.
• Ensure data integrity and compliance with ALCOA+ principles in all quality-related records.
• Lead investigations into deviations, non-conformances, out-of-specification (OOS) results, and ensure timely resolution with effective CAPA implementation.
• Identify potential risks to product quality and patient safety, and develop mitigation strategies.
• Conduct root cause analysis (RCA) and ensure implementation of continuous improvement initiatives.
• Provide training and guidance to QA, production, and other plant personnel on cGMP, quality systems, and compliance aspects.
• Build and maintain a high-performing QA team by fostering a culture of quality, accountability, and continuous improvement.
• Oversee the qualification and periodic evaluation of raw material and packaging material suppliers, contract manufacturers, and service providers.
• Ensure the implementation of robust vendor audit programs to maintain compliance with regulatory and internal quality standards.
• Stay updated with regulatory trends, new guidelines, and best practices in aseptic manufacturing and quality assurance.