Your new company

Your new role

• Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.
• Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.
• Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
• Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.
• Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.
• Participate in change control processes, assessing the impact of system changes and ensuring appropriate validation activities are performed.

What you'll need to succeed

• Bachelor’s degree in computer science, Engineering, or a related field.
• Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• 5+ Years experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
• Familiarity with validation methodologies, including risk-based validation approaches.
• Proficiency in creating and executing validation protocols and documenting validation activities.
• Excellent analytical and problem-solving skills, with attention to detail.
• Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
• Ability to work independently and manage multiple projects simultaneously.
• Knowledge of software development life cycle (SDLC) and change control processes.
• Understanding of data integrity principles and practices.

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or Pawel Jurkiewicz on 083 4487062 now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.