We are looking for a Business Quality Assurance Associate to join our Affiliate Pharmacovigilance QC team in Budapest.
•Provide adequate support during external/ internal Audits.
•Effectiveness check of cumulative Corrective Action Preventive Action (CAPAs) and corresponding actions.
•Liaise with Operations team for risk assessment for any new activity/site to find out gaps and help in preparation of Mitigation/Improvement plan.
•Perform evaluation of the process and procedures to find out gaps and help liaise with business for its mitigation and improvement plan
•Perform self-assessment for PV projects and publish the report to the Operations team.
•Ensure appropriate Root Cause Analysis (RCA) and Corrective Action Preventive Action (CAPA) are performed for KPI and SLA targets as applicable.
•Help in deviation tacking and completion of all the actions pertaining to the deviations.
•Perform all BQA related activities for PV projects as per BQA oversight document
•Help to ensure that any change in regulation/process is implemented by the business in time.
•Monitor RCA CAPAs as per target action date
•Conduct connect sessions for all sites on regular basis
•Review of RCA CAPAs, Standard Operating Procedures (SOPs), Standard Word Instructions (SWIs), Quality Control Plan (QCP), role description and other standard process documents as applicable
•Support inspection readiness team
•You are a graduate in Life Sciences/Pharmacy or Medical Degree
•You have min 2 years of Pharmacovigilance experience
•You have experience in a similar Business Quality Assurance role
To apply please send your CV to Noemi.Fenyvesi@cognizant.com or apply on the career site.
Job Location : Budapest, Budapest, Hungary
Employee Status : Full Time Employee
Shift : Day Job
Travel : No
Job Posting : Oct 02 2018
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