Executive - Quality Assurance

Inde, Maharashtra, Mumbai

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  • QA SOPs preparation and implementation in line with the Roche PQS by performing local impact assessment with Global SOPs
  • Accountable for the implementation of the local batch release procedure in accordance with company procedures and Health Authorities (HA) regulations
  • Finished Goods Shipment Release: Issue Ready To Market (RTM) for Import Shipments
  • Issue Ready to Market in SAP for stocks dispatched from Warehouse to Carrying & Forwarding Agents (CFAs) and inter CFAs
  • Report FHLR-Complaint Management, complaints related to import shipments (e.g. Damage to shipments, Packaging Defects, etc.)
  • Handling of Product Complaints and Closure in TrackWise System
  • Perform monthly product complaint reconciliation with Drug Safety team
  • Perform quarterly product complaint reconciliation with Med-Info team, Drug Safety team and distributor partner
  • Initiate Corrective Action and Preventive Action (CAPA) in TrackWise CAPA System
  • Initiate and Close Deviations in Discrepancy Management Online System
  • Initiate and Close Change Control in Technical Change Control System
  • Is accountable for the approval/rejection decision of returned products evaluated for re-introduction to the saleable stock.
  • Participate in Monthly QA regional meetings and update affiliate QA tasks in the meeting
  • Handle recalls and perform mock recalls as per Global Procedures
  • Support to ongoing and upcoming QA projects to achieve the organizational goals.
  • To prepare and comply for affiliate self-inspection.
  • Perform risk assessment for Affiliate QA activities and changes as per change control.
  • Preparation and collation of various PQS data for Operational and Strategic review. (QSMR)
  • Preparation of Quality Agreements for service providers and vendors related to QA functions.
  • Ensures quality oversight (as per defined strategy) of Good Distribution, Storage and Handling Practices related to Suppliers/Service Providers, e.g. Warehouse, Redressing Site and C&FAs.
  • Perform QA Audit & Visit Warehouse, Redressing Site and C&FAs to review activities for ensuring compliance to SOPs & Roche Quality Standards.
  • Perform QA audits of vendors related to QA functions.
  • Review of Quality related KPI and self-Inspection for CFA and warehouse.
  • Oversight of storage facilities and review mapping data of storage areas at pre-defined intervals of Warehouse and CFAs
  • Impart training on QA guidelines, Roche local SOPs as applicable to Warehouse, Redressing Site and CFA personnel’s.
  • Support redressing activities: Review of Job Orders and BPRs
  • Review of Qualification and Validation reports of Storage areas and Packaging Materials.
  • To monitor the destruction activity of the products at warehouse.
  • Visit distributors and perform QA re-assessment of existing distributors as per checklist.
  • Collaborate with internal stake holders for routine QA activities

Roche is an equal opportunity employer.

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