Senior Computer System Validation Manager

Senior Computer System Validation Manager

Octapharma

Vienna, Austria

Your tasks are diverse – from validation of corporate documents to developing strategy. This includes:

  • Plan and manage assigned computer system validation projects ensuring the validation of corporate computerized systems used across GxP-operations are conducted in compliance with applicable regulatory requirements and internal procedures;
  • Track validation deliverables and provide periodic progress reports to stakeholders;
  • Author, review and/or approve applicable documentation such as specifications, SOPs, validation plans and reports, test protocols and reports;
  • Executes/facilities gap analysis and/or risk assessments to ensure evaluation of current computer systems to ensure compliance with part 21 CFR Part 11, Annex 11, and GAMP 5;
  • Conduct impact assessments for changes impacting validated computerized systems. Acts as change owner for assigned projects;
  • Act as subject matter expert during regulatory inspections;
  • Provide coaching, training and/or mentoring to System Administrators, IT Technicians and Contractors.

What we expect?

  • Bachelor’s Degree in Computer Science, Electrical Engineering, Chemical Engineering or other Technical Science with minimum 5 years experience in the field of pharmaceutical industry related to qualification and validation practices;
  • Experience in planning, deploying, managing and sustaining computer system validations;
  • Ability to manage validation and qualification activities and good business process understanding;
  • Experience from ERP/SAP and MES systems is a strong advantage;
  • Excellent command of English;
  • Strong collaboration skills through international organizations and team player mindset.

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© EuroJobsites 2018

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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