თარიღები: 26 ივლ - 19 აგვ
მდებარეობა: თბილისი
დასაქმების ფორმა: სრული განაკვეთი
განათლება: ბაკალავრი
ენები: ინგლისური
ელ. ფოსტა: vacancy@gmpgeo.com
ინფორმაციული ტექნოლოგიები:  IT სპეციალისტი ინფორმაციული ტექნოლოგიები (ზოგადი)

GM Pharma is announcing a vacancy for the position of  IT Validation Manager

 

Work type: full-time



Responsibilities:

  • Plan and coordinate computer system validation (CSV) projects;
  • Active support in the conception, implementation and operation of validation measures along pharmaceutical processes and taking into account quality, cost and timeline requirements;
  • The integration of stakeholders from different functions and 3rd parties are part of your tasks;
  • Participate as SME to the URS preparation: You support the project team in the analysis of customer requirements and the creation of solution concepts for later implementation and changes;
  • Perform impact and risk assessments, design and prepare qualification / validation documents;
  • Provide regulatory compliance and computer validation guidance and support;
  • Create system validation deliverables (validation plan, user requirements, risk analysis, test protocols, validation reports);
  • Maintain SOPs (Standard Operating Procedures);
  • Plan and coordinate the validation testing;
  • Perform system audits for compliance with good practices and regulatory requirements;
  • Assist in setting up a quality management system;
  • Maintain the validation status of existing computerized systems according to a predefined frequency and in accordance with current internal SOPs;
  • Ensure compliance of the validation standards of the computerized systems through the continuous updating of procedures, according to international regulation and standards (GxP, GAMP5);
  • Ensure Infrastructure (Network, Servers, Database) Qualification documents are created, updated and reviewed on the defined Quality standards and on time on the regular bases;

 


Requirements: 

  • Higher or professional degree in Informational Technologies  
  • Good understanding of quality management systems;
  • Have experience and good understanding of the regulations and industry standards such as ISO, ITIL, COBIT and GAMP;
  • Experience in working in regulated industries;
  • Fluent language skills in English;
  • Good to have experience with validation of ERP systems;
  • Experience in the development of validation plans and their implementation and know how to find and implement viable solutions in an environment of competing interests;
  • Several years of professional experience in computerized system validation (CSV) in several projects;
  • Good understanding of GAMP processes;
  • Ability to write clear documentation and communicate complex information simply and accurately to both technical and non-technical audiences;



Please send your resume to the following email address:  vacancy@gmpgeo.com  and in a subject line indicate the position you are applying for.


მსგავსი განცხადებები
დისტანციური მხარდაჭერის უმცროსი სპეციალისტი

საქართველოს ბანკი


05 ივლ - 03 აგვ

.NET Developer

Flat Rock Technology


05 ივლ - 03 აგვ

logo

Android Developer

Flat Rock Technology


15 ივლ - 13 აგვ

logo

Core Banking Support Engineer

FINCA Impact Finance


30 ივნ - 29 ივლ

logo

Front-End Team Lead

Flat Rock Technology


05 ივლ - 03 აგვ

logo

IBANK & BOG.GE Solution Architect

საქართველოს ბანკი


21 ივლ - 19 აგვ

Information Security Sales Engineer

ჰაი-ტექ სოლუშენს


22 ივლ - 14 აგვ



NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV
NoLogoAvailable
დატოვე CV