T-873 Quality Assurance Executive

T-873 Quality Assurance Executive

13 Nov
Siora Surgicals Pvt. Ltd.

13 Nov

Siora Surgicals Pvt. Ltd.


Job Description

Create and maintain company quality documentation, such as manuals, procedures, etc.

Continuously improve QA processes and procedures.

The Preparation of QA reports.

Implementation and improvement in Quality Management System as per ISO 13485:2016.

Implementation & Formation of Standard Operating Procedure (SOP) & Protocols as per GMP.

Maintain complete documents of various departments like Site Master File, Device Master File with easy archival/retrieval.

Involve onsite into the calibration & Validation activities. Preparation of Calibration calendar and preventive maintenance.

Assist in preparation of Batch Manufacturing Record as per manufacturing and their review before release of the batch.

Giving line clearance before starting the New Batch.

Review and analysis of Environmental Monitoring plan to monitor environmental condition and hygiene of Personnel working in manufacturing areas and other controlled areas.

Experience of CE, ISO 13485:2016 and GMP Inspections.

Experience of Risk Management as per ISO 14971

Experience of Design & development file as per ISO 13485:2016

Knowledge of Post Market Surveillance and Post Market Clinical Follow Up, Product recall-Handling and handling market complaints as per SOP and maintaining its records.

Education- UG: B Tech in Mechanical, BE - Bio Medical, B. Pharma, B. Tech Medical Science Implementation and improvement in Quality Management System as per ISO 13485:2016.

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