Quality Specialist

3 days ago

Rajkot, Gujarat, India Alkem Laboratories Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Roles & Responsibilities:

  1. Quality Oversight

  2. Supervise and implement quality control measures across manufacturing operations to ensure compliance with ISO 13485, FDA QSR, and other applicable regulatory standards.

  3. Conduct regular in-process and final inspections of products to identify defects and ensure they meet specifications.

  4. Manufacturing Process Monitoring

  5. Collaborate with manufacturing teams to monitor and control production processes, ensuring adherence to Good Manufacturing Practices (GMP).

  6. Review and approve manufacturing process documentation, including SOPs, work instructions, and validation protocols.

  7. Quality Systems Management

  8. Maintain and support the quality management system (QMS), including corrective action and preventive action (CAPA), non-conformance, and complaint handling.

  9. Conduct root cause analyses and drive effective CAPAs for product and process non-conformances.

  10. Risk Management

  11. Participate in risk management activities, such as Failure Mode and Effects Analysis (FMEA), to assess and mitigate risks related to manufacturing processes.

  12. Support the creation of risk management files in compliance with ISO 14971 standards.

  13. Documentation and Reporting

  14. Prepare, review, and maintain quality documentation, including batch records, inspection records, and test reports.

  15. Ensure accurate and timely reporting of quality metrics, and present findings to management.

  16. Internal and External Audits

  17. Participate in internal audits to ensure compliance with regulatory and quality standards.

  18. Support external audits by regulatory agencies, notified bodies, and customers as needed.

  19. Continuous Improvement

  20. Identify opportunities for improvement within the manufacturing process and participate in continuous improvement initiatives.

  21. Collaborate with cross-functional teams, including engineering, R&D, and production, to enhance product quality and operational efficiency.

  22. Training

  23. Provide training and guidance to production staff on quality control and manufacturing best practices.

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