Job Description

HR/14 JOB DESCRIPTION FOR STAFF

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Job Purpose:

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Assist in maintaining and improving company's quality system.

Functional Responsibilities:

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Updating Device Master Records (DMRs) as per customer and registration requirements. Updating RMMS (raw material master specifications as and when introduced into the Quality System. Assist in updation of Technical files as per requirements. Maintaining Quality Management System documentation as per standard / guideline requirements. (E.g. ISO 13485, 21 CFR 820, EU or MoH of CIS countries). Assisting in organizing & documenting six monthly MRM and maintaining all documents as per requirements. Preparation and compilation of machine manuals, SOPs, WIs & Quality formats related documentation. Assisting in closure of NC and CAPA raised from external / internal audits Contribute in shop floor QA related activities for understanding of existing & new products Assist in documentation related to internal audits in the company. Conducting shop floor training as per Quality training calendar and maintaining records. Maintenance of external documentation such as documents sent to customers Ensuring timely calibrations of instruments/ equipment and compilation of calibration certificates in close coordination with Quality Control. Assisting in Design Dossier preparation. Complaint handling and maintaining complaint log.

Competencies

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B.Tech/B. Pharma/M. Pharma with 3-5yrs of experience in Quality Assurance. Knowledge of Quality Management Systems. Fair communication skills and computers skills, able to work with basic MS office Experience in Medical device Industry will be a bonus. Result orientation Working with and through others Customer centricity

Reporting to:

AGM

Department:

Quality Assurance

Position:

Sr.Executive

Relevant Experience:

3 - 5 Years


Rev 04 Effective Date 09-09-2023 Page 1