30-Points Job Description of Quality Control Manager in Pharmaceutical Industry

Rahul Kashyap

 30-Points Job Description of Quality Control Manager in Pharmaceutical Industry

  1. Oversee the development and implementation of quality control policies and procedures in accordance with cGMP and other relevant pharmaceutical industry regulations
  2. Ensure that all products and processes meet applicable standards and regulations, including FDA and EU requirements
  3. Conduct inspections and audits to identify areas for improvement and ensure compliance with regulatory requirements
  4. Develop and maintain quality control metrics and reporting systems
  5. Manage the quality control team, including hiring, training, and performance evaluations
  6. Collaborate with other departments to resolve quality issues and improve processes
  7. Act as the primary point of contact for quality control-related inquiries from customers and regulatory agencies
  8. Establish and maintain relationships with external testing and certification organizations
  9. Investigate and resolve customer complaints related to quality
  10. Monitor and analyze trends in customer feedback and implement strategies to improve customer satisfaction
  11. Ensure that the quality control laboratory is properly equipped and calibrated
  12. Oversee the maintenance and calibration of quality control equipment
  13. Develop and implement a system for tracking and trending laboratory data
  14. Review and approve quality control documents, such as test results and batch records
  15. Participate in risk assessment and risk management activities
  16. Lead continuous improvement initiatives to enhance quality control processes
  17. Develop and deliver training on quality control policies and procedures to employees
  18. Participate in the development and review of standard operating procedures
  19. Collaborate with research and development teams to ensure that new products meet quality control standards
  20. Monitor industry trends and developments and stay up-to-date on new quality control technologies and best practices
  21. Ensure compliance with all relevant laws, regulations, and standards, including cGMP, FDA, and EU requirements
  22. Develop and manage the quality control budget
  23. Prepare reports and presentations for management and regulatory agencies as needed
  24. Participate in the development of the company's quality management system
  25. Review and approve supplier agreements and conduct supplier audits as needed
  26. Develop and maintain relationships with key suppliers to ensure consistent quality of materials and components
  27. Conduct root cause analysis and implement corrective actions as needed
  28. Review and approve change control requests to ensure that changes do not negatively impact product quality
  29. Oversee the investigation and resolution of quality deviations and failures
  30. Ensure that the quality control department has the necessary resources and support to effectively carry out its duties in accordance with cGMP and other relevant pharmaceutical industry regulations.

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