Computer System Validation (CSV) Expert - META

Job description

Managing validation activities and documentation related to the deployment of GBS (Global Business Services System) in META (Middle East, Turkey and Africa) region and act as Computer System Validation & Compliance for the GxP related computer systems implemented in META. LBA (Local Busniess Administrator)/Key user of GxP computer systems, IDEA for CON (a document management system), LOS (Leaning One Source - BI Training system) and Go Track providing first line support to the end users and be the contact person with corporate system owners.

Job Profile

· Acts as a Validation Manager for GBS: Ensures the validation status and the System Life Cycle management by creating and reviewing documents, setting up change controls, executing documented tests, contacting System owners, IS and CSV & C.Provides first level support (trains/ advises users, opens incidents to address errors to IS, organize key users forums, etc.).
· Ensures the set up and maintenance of IDEA for CON for local/regional SOPs/Working Instructions (Creation, processing, distribution, access, revision and archiving); Acts as the Local Business Administrator of IDEA for CON and the Key User providing first level support to end users.
· Ensures that an effective Deviation and CAPA system (GoTrack) is established and maintained. Acts as the LBA and key user of GoTrack system in META.
· Assumes role as local QA for CSV & C (Computer Systems Validation & Compliance) during project and operational use of IT systems supporting GxP relevant processes within Operations
· Establishes and maintains list of GxP relevant IT systems
· Represents local QA function in local/global IT project teams
· Reviews and approves validation documentation for local IT systems/ client site systems in case of global systems
· Performs audits and self-inspections to ensure compliance with internal SOPs and OCP/OCS requirements and external regulations
· Acts as first contact during audits by authorities, in case of global IT systems present overall validation approach and liaises with validation function at Corporate

Requirements

· 2-5 years of experience in computer system validation with quality compliance and assurance in MNC pharmaceutical company
· Bachelor's degree
· Fleuncy in English
· Demonstrates a commitment to quality in all work. Sets high goals for standards, performance for self and others. Plans, does, checks, acts.
· Good negotiation and effective influencing skills. Develops and maintains constructive relationships internally and externally
· Must possess strong analytical and problem solving skills
· Ability to appropriately balance compliance and business needs to ensure problems are identified, clearly articulated and resolved with the right sensitivity to timing, risk consideration and overall business impact
· Team player, engaging, developing oneself, co-operating, advising, guiding people, coaching and developing others, structuring work

· Willingness to travel 30% of time