Job
Description
The Opportunity: The QA Specialist in IND plays a crucial role in overseeing the quality assurance processes across the companys three manufacturing sites (Mumbai, Panoli, and Dehradun). The core responsibility of this position is managing and resolving non - product qualit y issues, ensuring adherence to quality control procedures, and maintaining product excellence by collaborating with various teams, the specialist acts as the primary contact for resolving non - conformance issues and minimizing the recurrence of quality pr oblems. QA Specialist is a vital role that ensures high standards of product quality, operational excellence, and regulatory compliance across the companys manufacturing operations. What were looking for: Education: B.Sc/M.Sc (Chemistry, Biology, Microbiology) Experience: Minimum 5-8 years of experience How you will thrive and create an impact: 1. Non-Product Quality Issue Management: Identify, document, and resolve non-product related quality issues across the Mumbai, Panoli, and Dehradun manufacturing sites. Ensure compliance with established quality control procedures, work instructions, and GMP standards. Monitor and address non-conformance issues to prevent recurrence, coordinating with relevant teams and departments. 2 . Site Coordination & Communication: Serve as a liaison between the three manufacturing sites, ensuring smooth communication and effective resolution of non-product quality issues. Collaborate with site managers, production teams, and quality specialists to ensure consistent quality control practices across all sites. 3. Compliance with Regulatory Requirements: Ensure actions taken to address non-product quality issues comply with internal policies and external regulatory requirements (e.g., GMP, ISO). Perform audits, review documentation (e.g., COA/COC), and ensure adherence to quality standards at all times. 4. Root Cause Analysis and Corrective Actions: Utilize problem-solving tools like 5M+E and 5 Whys to identify root causes of non-product quality issues. Implement corrective actions across all three sites to ensure issues are effectively addressed and do not recur. 5. Continuous Improvement: Drive continuous improvement initiatives to optimize processes and reduce non-conformance issues. Collaborate with site-specific and regional teams to improve overall product quality and operational efficiency. 6. Documentation and Reporting: Oversee the documentation of non-product quality issues and track trends to ensure timely resolution. Prepare and maintain accurate and timely reports on quality control activities and issues identified across all sites. 7 . Customer Complaint Investigations: Lead and manage all investigations related to customer complaints, ensuring thorough root cause analysis and timely resolution to improve customer satisfaction. 8. Audit Oversight: Oversee internal and external audits to ensure compliance with ISO 9001:2015, Medical Devices, GDP, and other relevant standards. Serve as the appointed Lead Auditor for relevant certifications, ensuring audits align with regulatory requirements. 9. Quality Management Systems (QMS): Develop, implement, and maintain the QMS to ensure compliance with ISO regulatory standards. Drive the continuous improvement of the QMS by incorporating best practices, process enhancements, and risk mitigation strategies. 10. Document Management: Oversee the document control system to ensure all documentation is up-to-date, compliant, and easily accessible for review during audits. 11. ETQ System Development and Training: Lead the development and training of the ETQ system across the DC IND to ensure teams are proficient in system usage for quality management and compliance. 12. Quality Culture and Continuous Improvement: Foster a culture of continuous improvement at the IND manufacturing site, guiding cross-functional teams to optimize quality performance. Spearhead quality improvement initiatives, encouraging a culture of excellence across all operations. 13. Third-Party Logistics & Warehouse Audits: Oversee audits of third-party logistics providers and extended warehouses, ensuring compliance with quality standards and regulatory requirements. 14. Certification Management: Lead and maintain certification audits to ensure compliance with ISO and industry-specific standards. Ensure the organization consistently meets regulatory demands. 15. Essential Skills and Qualifications: Extensive experience in quality assurance within regulated industries (ISO 9001:2015, Medical Devices, GDP). Strong knowledge of QMS, audit processes, and document control. Proven ability to lead and manage cross-functional teams in driving continuous improvement and compliance. Strong analytical skills, with experience in customer complaint investigations. Certification in ISO lead auditing or similar credentials. Excellent communication, leadership, and training skills. 16. Support Label Replacement Requests: Work closely with the supply chain led to support label replacement requests. Coordinate actions related to containment and corrective actions if needed to address any quality issues.
