QA Ra Executive

2 weeks ago

Vatva Ahmedabad Gujarat, India Shree Umiya Surgical Pvt. Ltd. Full time

**QA RA Executive**

**Position: 1**

**Reports to: Managing Director**

**Job Location: Plot No.4002,GIDC Vatva,Ahmedabad**

**Qualification: M.sc., B.Pharm M.Pharm or Equivalent**

**Experience: 1-4 year**

**Pay and perks: Best in the industry**

**Roles and Responsibilities**:
1. Prepare, review, and update standard operating procedures (SOPs), work instructions, and quality manuals.

2. Ensure that all quality documents are prepared, maintained, and controlled in line with regulatory requirements.

3. Prepare detailed internal audit reports highlighting observations, non-conformances, and opportunities for improvement.

4. Conduct Management Review Meetings (MRM) to present audit findings, KPI/KPR performance, and areas for system improvement.

5. Propose and implement corrective actions based on audit findings to improve system efficiency and achieve maximum output with accuracy

6. Issue BMRs to production departments, ensuring accuracy and alignment with the production schedule.

7. Review completed BMRs for correctness, completeness, and adherence to established procedures and regulatory requirements.

8. Approve finalized BMRs for product release after ensuring all critical parameters and documentation meet quality standards.

9. Final Inspection for Batch release

10. Ensure all QA activities align with ISO 13485:2016 and EU MDR CE requirements.

11. Maintain documentation and records for regulatory compliance, including device master records (DMRs), technical files, and risk management documentation.

12. Random Inspection of process at different stages.

13. Develop and maintain a calibration schedule for all equipment and instruments used in production, quality control, and testing.

14. Ensure timely calibration of equipment to maintain accuracy and reliability in processes.

15. Oversee validation activities for equipment, processes, and systems, ensuring compliance with regulatory and company standards

16. Ensure that product labels are finalized in compliance with EU MDR Guidelines and any specific buyer requirements.

17. Maintain comprehensive and accurate records of all QA-related activities, including calibration, validation, and compliance documentation.

18. Conduct training sessions for employees on QMS requirements, ISO 13485, EU MDR, calibration, and validation procedures.

19. Ensure that employees are aware of their responsibilities in maintaining product quality and regulatory compliance.

20. Initiate and manage Corrective and Preventive Actions (CAPAs) to address identified issues and prevent recurrence.

21. Identify areas for improvement in QA processes and recommend enhancements to ensure operational excellence.

22. Strong analytical and problem-solving abilities.

23. Look after Primary secondary and bar code for appropriate artwork of packaging material

Pay: ₹15,109.77 - ₹18,021.45 per month

**Benefits**:

- Cell phone reimbursement

Schedule:

- Day shift

Work Location: In person

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