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.