Novo Nordisk Pharmaceutical Science Job – Quality Associate
Novo Nordisk quality associate job opening 2022. Pharmaceutical science job opening 2022. BSc Pharmaceutical Science job, MSc Pharmaceutical Science job Opening 2022. Pharmaceutical science job vacancy, Intrested and eligible candidates may check out all the details on the same below:
Job Title: Quality Associate
Location Bangalore, India
Job category Quality
Eligbility Criteria
Graduate/Post-Graduate in Pharmaceutical Sciences. 6 + years of experience in the pharmaceutical industry
The Position
The position holder is responsible to Ensure QMS (Quality Management System) in affiliate is in compliance to 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 affiliate, approval, 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 for reviewing and approving the validation protocol and reporting for all the temperature distribution study conducted at the distributor’s sites and calibration certificates of cold rooms conducted at 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 Audit plan and conduct audit 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).
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