Relevant Experience: 3 - 5 Years
Reporting to: AGM
Department: Quality Assurance
Assist in maintaining and improving company’s quality system.
- 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.
- B.Tech/B. Pharma/M. Pharma with 3-5 years 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
