Vendor Management

3 days ago

Ahmedabad, Gujarat, India zydus lifesciences Full time ₹ 9,00,000 - ₹ 12,00,000 per year
Job Description

: Vendor Audit & Compliance

  • Procurement bill of material (PBOM) review
  • Initiation and evaluation of change control, CAPA through track wise software.
  • To evaluate CEP updation, DMF notification and Vendor notification for implementation at formulation sites.
  • Review of QMS documents of all sites.
  • Auditing of formulation sites as per self-inspection plan.
  • Preparation of Audit planner for Active pharmaceuticals Ingredients, Excipients, packing materials, KSM/Intermediates, Sterile articles, Vaccine Materials, Service provider, Contract laboratories.
  • To assign source of Active pharmaceuticals Ingredients, excipients, packing materials in SAP based on availability of documents.
  • Retest period extension of Active pharmaceuticals Ingredients, excipients and packing materials in SAP.
  • Updation of shelf life, storage conditions, Retest /Expiry flag and inspection interval data in SAP for Active pharmaceuticals Ingredients, excipients and packing materials.
  • To Review and approval of new and revised specification and standard test procedure of drug substance, excipients, packaging materials and drug products.
  • To do impact assessment of drug products manufactured at formulation site in case of any critical observation/GMP alert received at vendor sites.
  • To prepare and review of Nitrosamine and Azide Impurity Assessment reports.
  • Review of Technical documents of Active pharmaceuticals ingredients, excipients, packing material, KSM/intermediates, Service provider, sterile articles, vaccine materials and External Testing laboratory.
  • Support to manufacturing sites during regulatory and customer audits.
  • To perform any other activity assigned by HOD as and when required.

Locations: Corporate Office | Corp. Office, Ahmedabad, Gujarat, India

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