Quality Assurance jobs at Roche, Mumbai. Roche has released the jobs for pharma candidates for the post of Executive in Quality Assurance department. Check out complete details here.
Job Title: Executive – Quality Assurance
- Graduate and Post-Graduation is Pharmaceutical Sciences
- The employee has an overall experience in Quality Assurance function with a minimum of 3 years in the Industry (Pharmaceutical / Biotech)
- The employee having good exposure of facing QA Audits and can perform QA Audits
- Having knowledge on online QMS systems and SAP.
Job Location: Mumbai, Maharashtra
- To monitor and maintain quality products to the patients from warehousing, storage and distribution of the products and ensuring the right products to the 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 personnels.
- 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 the warehouse.
- Review of Site Master File for Warehouse and CFAs
- Perform due diligence of 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