Quality Associate | Novo Nordisk | Bangalore

Job Description

The Position

The position holder is responsible to Ensure QMS (Quality Management System) in the affiliate is in compliance with Novo Nordisk and external requirements and manage affiliate Quality Associate (QA) activities.

• Documentation Control and Repackaging: You will be responsible for the content responsible for Indian affiliates, approval, and uploading of local procedures in Quality Docs. Handling reviews and comments on procedure drafts. SOP (Standard Operating Process) expert in the affiliate and approve SOP deviations. Maintenance and distribution of procedures. Review and approve the Batch documentation of Repackaging.
• Validation and Calibrations: You will be responsible to review and approve the validation protocol and report for all the temperature distribution study conducted in the distributor’s sites and also of calibration certificates of cold rooms conducted at the distributor’s sites as part of validation.
• Quality Control (QC) and Quality Management Review (QMR): You will verify clinical safety reports and post-marketing safety reports before reporting to concerned Indian regulatory authorities. QC of logging of customer contacts. Prepare data and inputs for QMR. Prepare MOM (Minutes of the Meeting) with the identified Action points- Implement and follow up for the completion of action points.
• Audits: You will act as GDP Lead Auditor and prepare an Audit plan and conduct an audit of external suppliers. Ensure Quality compliance with Audits and Authority Inspections. Follow-up and closure of audit findings issued during HQ and Local Audits.
• Warehouse and Storage: You will do Quality Oversight for NN licensed warehouse and product storage areas. Quality Oversight on storage and product movements as per NN QMS and License requirements in HO (Refrigerator Room).

Qualifications

• Graduate/Post-Graduate in Pharmaceutical Sciences or Post-Graduate in life science.
• 6 + years of experience in the pharmaceutical industry