Quality Assurance Manager Roche Posted on January 14, 2020 2 - 4 years Cairo - Egypt Any Graduation. Any Nationality Send Me Jobs Like This SEND Alert Set Successfully Opening 01 Job Description EMAIL JOB SEND Email sent successfully. SHARE JOB 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 quality2. 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 productRoche is an equal opportunity employer.Research & Development, Research & Development > Clinical Development Company Industry Medical / Healthcare / Diagnostics / Medical Devices Department/Functional Area Quality / Testing / QA / QC / Inspector Keywords Quality Assurance Manager REPORT THIS JOB Disclaimer: Naukrigulf.com is only a platform to bring jobseekers & employers together. Applicants are advised to research the bonafides of the prospective employer independently. We do NOT endorse any requests for money payments and strictly advice against sharing personal or bank related information.We also recommend you visit Security Advice for more information. If you suspect any fraud or malpractice, email us at firstname.lastname@example.org People Looking for Manager Quality Assurance Jobs also searched Manager Quality Assurance Jobs QA Manager Jobs Head Quality Assurance Jobs Quality Jobs GMP Jobs Cold Chain Jobs Change Control Jobs Roche View Contact Details Contact Name/ Designation: - Website https://roche.wd3.myworkdayjobs.com/roche-ext/job/Quality-Assurance-Manager_202001-100883 Additional Information Required Employer has requested some additional information along with your application for this job Cancel Login to Naukrigulf Continue using GOOGLE FACEBOOK All your activity will remain private or Forgot Password?