To monitor and maintain quality products to the patients from warehousing, storage and distribution of the products and ensuring the right products to right patient.
Provide response and investigate queries / complaints related to product quality.
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.
Face quality audits, support audit requirements, and perform timely CAPA closure.
Participate in Monthly QA regional meetings and update affiliate QA tasks in the meeting
Participate in Annual Global and Regional Supply Chain & Quality Meeting
Handle issue management records, be a part of Local Expert Group (LEG) and participate in Global Expert Group (GEG).
Actively participate in Global Roche Anti-counterfeit Forum (GRACC) Meetings and calls
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 due diligence, commissioning, maintaining and de-commissioning activities of 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.
Responsible for Risk Management activities for CFA and Warehouse operations.
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.
Conduct monthly warehouse and CFA update meeting calls to oversight quality activities.
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.
Review of Site Master File for Warehouse and CFAs
Perform due diligence new distributor’s w.r.t. QA assessment checklist.
Visit distributors and perform QA re-assessment of existing distributors as per checklist.
Collaborate with internal stake holders for routine QA activities
Graduate and Post-Graduation is Pharmaceutical Sciences
Employee having an overall experience in Quality Assurance function with minimum 3 years in the Industry (Pharmaceutical / Biotech)
Employee having good exposure of facing QA Audits and can perform QA Audits
Having knowledge on online QMS systems and SAP.
Job Location: Mumbai (HO)
Roche is an equal opportunity employer.
Quality, Quality > Quality Assurance