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Quality Assurance Manager

Roche

Posted on January 14, 2020

2 - 4 years Cairo - Egypt

Any Graduation. Any Nationality

Opening 01

Job Description

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1. Implement and maintain the Quality System
•Maintain up to date knowledge of the relevant legal requirements and GMP/GDP regulations
•Documentation management Develop and maintain local procedures, in compliance with the Global Pharmaceutical Quality System Documents
•Perform self-inspections
•Manage Complaints, Recalls and Returns
•Handle Deviations and Investigations and local Corrective and Preventive Actions
•Training of personnel involved in GxP activities
•Change control
•Quality Risk Management
•Dealing with internal and external inquiries about the products quality
2. Ensure an uninterrupted supply of the products to the market
•Release commercial product batches to the local market and Investigational Medicinal Products to the local clinical investigation centers, according to the local regulations, Marketing Authorizations and Clinical Trial Authorizations
•Ensure compliance with GDP and GMP guidelines and regulations for the products distributed locally
•Ensure batch traceability for all batches received and distributed by the local warehouse
•Ensure appropriate supervision of the supply chain, and existence of additional controls for the cold chain
•Ensure Risk Management procedures are in place and risk assessments are maintained.
3. Management of GxP out-sourced activities
•Maintain Quality Agreements with local contracted third parties (Warehouse & Distribution, Contracted manufacturer, Contracted Laboratory)
•Manage Quality related aspects with local partners. (Perform Risk assessments where needed, Training, Batch review, Change control, deviation review, validation document review, temperature mapping oversight and review, review and analyze temperature data on defined intervals etc.)
•Peform audits of contracted third parties
•q2Review local Batch records when needed and provide release of imported and locally manufactured product
Roche is an equal opportunity employer.
Research & Development, Research & Development > Clinical Development


Quality / Testing / QA / QC / Inspector

Keywords

Quality Assurance Manager

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Roche


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