Minimum of 2 years work experience in qualityassurance and / or quality control and / or production / distributionin the pharmaceutical industry ?
Knowledgeable in Quality andGMP / GDP compliance. Audit experience is desirable ?Fairunderstanding of the quality and regulatory requirements Main areasof responsibility are : 1.
Quality Management System - Implementationand maintenance oMaintain up to date knowledge of the relevantlegal requirements and GMP / GDP regulations by getting Qualitytrainings and being informed.
oSupport to develop, implement andmaintain local procedures, in compliance with the GlobalPharmaceutical Quality System Documents as well as with locallegislation and GMP & GDP standards.
oSupport to evaluateproduct Quality issues and Discrepancies performing the root causeanalysis and ensuring that appropriate Corrective and Preventiveactions are taken.
oSupport to manage product Complaints, Recallsand Returns, when required oSupport to identify, organize andconduct training of personnel involved in GxP activities oSupportto implement and manage Change control, local Corrective andPreventive Actions and Quality Risk Management procedures as perthe local SOP and ROCHE guidelines oProvide timely feedback andguidance for dealing with internal and external inquiries about theproducts quality oSupport and maintain local supply chain qualityrisk management plan as per Roche global guidance 2.
QualityProcedures oSupport to release commercial product batches to thelocal market according to the local regulations and marketingauthorizations.
oSupport to ensure (Plan and execute) compliancewith the relevant GxP guidelines and regulations for the productsdistributed / manufactured locally.
oSupport, coordinate and managelocal SOP process oSupport to evaluate all discrepancies fromoutsourced warehouse & distribution and approve correctiveactions and review effectiveness of CAPAs as part of annual qualityreview 3.
General (Mandatory) : oAttend / complete all requisiteon-line and F2F trainings (Role specific, Safety responsibility andCompliance) within specified time limit