Quality Assurance

2 days ago

Noida, Uttar Pradesh, India Talent Vision Services Full time ₹ 5,00,000 - ₹ 15,00,000 per year
HR/14 JOB DESCRIPTION FOR STAFF
Job Purpose:

Assist in maintaining and improving company's quality system.

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.
  • 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 Page 1

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