officer - qa/ra

4 days ago

Chennai, Tamil Nadu, India PUNIT MEDITEK PRIVATE LIMITED Full time ₹ 3,60,000 - ₹ 4,20,000 per year

1.Preparation of Quality Management system documents

2.Responsible of control of all level Master copy, Control copy, & Obsolete of QMS documents

3.Responsible for Retrieval of all level of Obsolete documents for disposition as per the control of documents.

4.Internal Quality Audit – Scheduling, Conducting, Monitoring and follow up for closure.

5.Responsibility to update level II, III & level IV documents of QA as per review period and maintenance of Index.

6.Management of change control and change request and maintenance of register

7.Document retrieval and support during external, internal and corporate audits.

8.Responsible for Handling of customer complaints

9.Scheduling Management Review Meeting

10.Responsible for Non-Conformance & CAPA implementation and its effectiveness.

11.Responsible to manage quality operation team to ensure quality of product lines and its deliverables

12.Customer Complaint Follow up

13.Batch Processing Record (BPR) Issuance, Storage and Retrieval

14.Batch Processing Record (BMR) Issuance, Storage and Retrieval

15.To prepare and maintain the Medical device File as per IMDR 2017

  1. Responsible for preparation and submission of application to CDSCO and regular follow up for obtaining approval

  2. Responsible and support implementation of Indian and applicable regulatory regulation

18.Reviewing the performance of Quality Management System and Liasoning with external parties on matters relating to the same.

19.Ensuring that processes needed for the quality management system are documented. Reporting to the top management non the effectiveness of the quality management system and any need for improvement

20.Ensuring the promotion of awareness of applicable regulatory requirements and management system requirements throughout the organization.

21.Responsible for batch release (COA)

22.Support any other additional responsibilities as when required.

Job Types: Full-time, Permanent

Pay: ₹30, ₹35,000.00 per month

Benefits:

  • Food provided
  • Health insurance
  • Leave encashment
  • Paid sick time
  • Provident Fund

Work Location: In person

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