Associate - Quality Assurance & Regulatory Affairs

1 day ago

Bengaluru, India Niramai Full time

NIRAMAI Health Analytix is looking for a dynamic professional with strong interest in quality assurance and regulatory affairs to assist in implementing quality management system and regulatory strategies for maintaining compliance with established standards like ISO 13485, ISO 14971, IEC 62304 & 82304.

**Primary roles & responsibilities**:

- Support the creation, revision, and control of quality system documents needed to ensure product quality and adherence to applicable regulations.
- Assist in planning and execution of the audit activities necessary for monitoring the Quality Management system and participate as a team member in all internal/external audits.
- Assisting with MR to conduct management review meetings on defined intervals and record meeting minutes.
- Review and approve completed batch records and equipment logs for completeness and also ensure on time calibration activities and preventive maintenance is completed. Escalate issues for inappropriate handling.
- Track and support training activities to ensure on time training completion for all employees, this includes new employee training, skill training and change implementation training for new/revised documents.
- Support as required to track and report out the Quality metrics (CAPA, NCR’s, Supplier monitoring etc) on a periodic basis for the site by working closely with various functional groups.
- Responsible for market release of the products prior to shipment to customers.
- Assist in overall improvement of the product development throughout the lifecycle as per QMS.
- Prepare and Assist in global regulatory strategies and submissions.

**Requirements for the role**:

- Qualification: Graduate / Post Graduate
- Experience: A minimum experience of 1 to 2 years with a good knowledge on QMS, Documents handling, Inprocess quality checking
- Result orientation and willingness to take ownership
- Attention to details
- Excellent communication and interpersonal skills
- Ability to work with various stakeholders within and outside organization and positively influence team spirit

**About NIRAMAI Health Analytix Pvt Ltd

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