Head- Quality Assurance

Job Description

We are seeking an experienced Head in the Quality Assurance department to oversee and ensure the highest level of quality standards across our organization. The ideal candidate will have at least 15 years of experience in quality assurance, with a proven track record of managing and leading a team. 1. Quality Management System (QMS) Oversight Develop, implement, and maintain the Quality Management System in compliance with local and international regulations (e.g., CDSCO, WHO, USFDA, MHRA). Conduct regular reviews and updates of QA policies and procedures. 2. Regulatory Compliance Ensure all manufacturing processes and documentation comply with regulatory requirements. Prepare for and manage regulatory inspections and audits. Liaise with regulatory bodies and ensure timely submission of required documentation. 3. Product Quality Assurance Oversee all aspects of quality control for OSD formulations, including raw materials, in-process controls, and finished products. Approve or reject raw materials, intermediates, and finished products based on quality standards. 4. Quality Control (QC) Coordination Collaborate closely with the QC department to ensure proper testing of materials and products. Review and approve QC reports and ensure timely release of products. 5. Deviations and Investigations Lead investigations into quality incidents, deviations, or non-conformances. Implement corrective and preventive actions (CAPA) to prevent recurrence. 6. Documentation and Record Keeping Ensure proper documentation practices (GDP) are followed. Review and approve Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and other critical documents. 7. Training and Development Conduct training programs for QA and plant staff on quality standards, regulations, and best practices. Foster a culture of continuous improvement and compliance. 8. Supplier and Vendor Management Approve and audit suppliers and vendors to ensure the quality of raw materials and services. Ensure supplier compliance with quality agreements and standards. 9. Risk Management Identify, assess, and mitigate risks associated with product quality. Conduct risk assessments and implement control measures as necessary. 10. Cross-functional Collaboration Work closely with production, RD, and other departments to ensure quality is integrated into all processes. Provide QA support during product development and technology transfer. 11. Continuous Improvement Drive continuous improvement initiatives to enhance product quality and operational efficiency. Monitor industry trends and update practices accordingly. 12. Ethical and Safety Compliance Ensure all QA activities are conducted ethically and with a focus on employee and consumer safety. Promote a safe working environment and adherence to health and safety regulations. This role demands strong leadership, excellent communication skills, and a deep understanding of pharmaceutical quality standards and regulatory requirements Preferred candidate profile Head- Quality Assurance in EU approved OSD Pharma Plant Perks and benefits Company Family Accommodation will be provided Personal Mediclaim and Accident Insurance upto Rs 5 lakhs