Quality Assurance executive

Dear candidate,

We are hiring QA sr. executive.

Experience: 3+ years

CTC: as per industry standards

Location: Noida

Functional Responsibilities:

•  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:

•  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.

sadhna@careerahead.co.in

Thanks & Regards