Novo Nordisk Hiring Graduate, Post-Graduate for Quality Associate-Apply Now

As a Quality Associate your main responsibilities will be:

Documentation control and distribution responsible

• • Content responsible for Indian affiliate, Approval, uploading of local procedures in Quality Docs.
  • Handling reviews and comments on procedure drafts.
  • SOP expert in the affiliate and approve SOP deviations.
  • Maintenance and distribution of procedures.

Product Release

• Product Release Responsible for NN owned products in affiliates.
• Evaluation and release of NN A/S products.
• Release of repackaging batch with review and approve the batch documentation.

Training

• • Induction training of new employees as a part of iACE.
  • Affiliate ISOtrain responsible person (training coordinator).
  • Ongoing training on applicable procedures.

Repackaging

• • Co-ordinate with distributor and prepare repackaging plan for the products (e.g. Tender Requirements).
  • Review and approve the Batch documentation of Repackaging

Change control and Deviations

• • Initiation, implementation, and follow-up for completion of Change Control.
  • CR Expert and QA Approver.
  • Review and approval of deviations (planned/ unplanned) rose by all departments. Follow-up on action plans and closure within the timelines.

Destruction

• • Review for necessary approvals and document the destruction of NN products, archiving documents.

Validation

• • Review and approval of the validation protocol and report for all the temperature distribution study conducted in the distributor’s sites.
  • Review and approval of Periodic system evaluation (PSE) of cold rooms conducted at distributor’s sites.

Quality Control

• • Verify clinical expedited safety reports before reporting to concerned Indian regulatory authorities.
  • QC of logging of customer contacts.

Local Records Manager

• • Overall responsibility of handling the business-critical documents in the affiliate.
  • Train and support other departments.

Review Labeling Text Matter (QMR)

• • Review and ensure the Labeling Text Matter are complying with the local and product requirements. 

Qualifications

Below are the required skills

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