ROCHE Hiring Executive – Quality Assurance Graduate and Post-Graduation is Pharmaceutical Sciences Apply Now
Mumbai
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)
TO APPLY CLICK HERE
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