Responsibility :

1. Overall responsible to carry out daily production and development activities to achieve the target in balloon catheter assembly department.

2. Validation and furnish product requirement specification furnished for the development of new product.

3. To monitor machine and process validation carried as per QMS requirements.

4. To review and update SOP, Formats, MFC and all QMS documents as per QMS requirements.

5. Recruitment and Training to be given to new employees.

6. Identify opportunities for improvement.

7. Lead problem-solving activities within teams for process improvements.

8. Train team members for machine operation, process validation, documentation as per QMS requirements.

9. To maintain personal hygiene as per cGMP requirement.

10. To maintain a work environment as per QMS requirement.

11. To review the validation report for machine, process and product for balloon catheter.

12. To verify calibration details for all the machines.

13. To maintain the machine history records and breakdown maintenance.

14. To maintain all the machines in good condition.

15. To procure raw materials as per production requirement.

16. To review monthly production statements, planning and machine wise rejection analysis.

17. BMR (Batch Manufacturing Record) review and checking.

18. Responsible to take corrective and preventive action.

19. To ensure regular implementation of training programs as per requirement or training schedule.

20. To Participate and contribute in assessment of risk associated with the medical device in coordination with other risk management team members.

Authority :

- Authorized to take all relevant decisions in order to discharge the above responsibilities to meet the quality and productivity norms by the management.

- Authorize to make the changes in shift arrangements according to production requirement.

- Authorize to shuffle the manpower from one department to another department with prior permission from production head.

- To train the new employees for the given machines in balloon catheter assembly department.

- Signature at Authorized By for Operator validation in production area format.

- Signature at Authorized By for Balloon Catheter Assembly Batch Manufacturing Records.

- Signature at Authorized By in Batch wise planning for production in Balloon catheter assembly.

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