logo

JobNob

Your Career. Our Passion.

Quality Assurance Chemist


JOB PROVIDER BADDI


Location

Baddi | India


Job description

To check for accuracy and proofread content to ensure artworks produced are according to client's brand standards and guidelines. Ensure all Graphic Artists are informed of any changes or corrections. Work closely with commercial team to ensure that client's expectations and requirements are met.

great knowladge of pharma standerds as per FDA OR WHO

Develop and implement Quality Management System Quality Policy and

procedure as per ISO 13485:2016 and Medical Device Regulation 2017/745

Preparation and maintaining Site Master File, Device Master Files, Quality

Manual, and Validation Master Plan.

Ensuring Documents & Data Control

Handling of Market Complaints and Customer feedback activities

Handling of Control Sample Management System

Handling of calibration and preventive maintenance of all instruments and

machines in Co-ordination with concern department and external agencies.

Review of new/revised Artwork Design such as Blister Packing, IFU. With

compliance of ISO 15223:2021 as well as regulatory requirements

Prepare and update risk Management report as per ISO 14971:2019

Conducting internal audits, participating in regulatory & ISO audits &

observation closer for the same

Handling of Change Control Management

Uploading the documents in SUGAM portal and verifying updates or status

Maintain the Post Market Surveillance Data

Ensuring the Testing and Sampling of products meet with set standards and

specifications for regulatory compliance

Prepare the Management Review Meeting records

Maintaining Correction and corrective action as well as Preventive action


Job tags



Salary

All rights reserved