Computer System Validation Specialist - CSV Specialist

Key Responsibilities

• Overseeing CSV projects in areas such as document management, IT infrastructure, pharmacovigilance, maintenance, and application management.
• Planning, management and execution of CSV projects.
• Development and implementation of validation documentation.
• Planning and conducting tests including documentation in accordance with GxP regulations.
• Creation, updating and further development of work instructions (SOPs) and project related documentation.
• Ensuring GxP-compliant operation of application systems.
• Supporting adaptations and changes (change management) in coordination with quality management.
• Reporting directly to the CSV Lead at our headquarters in Freiburg.
• Creating risk analyses, data maps and implementing the ALCOA principle to ensure data integrity.
• Primarily cooperating with the company’s German branch, while being employed by the Polish branch.
• Additionally, cooperation with other company branches.
• Business travel to Germany.
• Manage system validation documentation and records in strict adherence to data integrity and compliance standards.
• Participation in audits and inspections, and defending validation practices and documentation before regulatory authorities.

Our requirements

• Degree in computer science, pharmaceutical engineering, process engineering or similar.
• Minimum 2 years of practical experience in the validation of computerized systems (CSV).
• Proficiency with Atlassian tools is required.
• Excellent teamwork, communication, and problem-solving skills.
• Proficient in both written and spoken Polish and English at C1 level - necessary condition. Beneficial to have German but not mandatory.
• Strong team and performance orientation and flexibility.
• Demonstrates assertiveness, reliability, and the ability to work independently.
• Demonstrated ability to work autonomously in a dynamic, fast-paced environment.
• Proficiency in validation methodologies and quality management systems.
• Execute risk assessments, validation planning, protocol development, testing, and reporting.
• Nice to have: understanding of GxP regulations is an advantage.

What will you receive after the trial period?

• Co-financing for Multisport/Medicover Sport. We take care of our employees. We want them to be satisfied, active, and healthy.
• Co-financing for Medicover/LuxMed. We all know that health is the most important thing!
• Company Social Benefit - we have launched the ZFŚS in our company to support social activities for employees and their families.
• Quarterly bonuses. We appreciate your commitment - achieve your goals and enjoy additional rewards for your work and contribution to the company’s growth.
• Employee referral program - Love working with us? Refer a friend and earn a bonus.
• Internal and external training - we learn and grow. Develop your career with us!
• We enjoy spending time together, so we organize company breakfasts and integration events.
• We offer English classes. Advanced learners also have the opportunity to study German.
• Celebrate your birthday with an extra day off.
• Comfort guaranteed - comfortable workstations, laptops, and all the equipment you need.

About Komtur

The Komtur Pharmaceutical Group is a global wholesaler and specialized service provider for the pharmaceutical and biotech industry. We offer customized solutions in the areas of clinical trial supply and clinical distribution, international pre-marketing, global market access solutions (specialty distribution) and individual imports for patients, including narcotics. We have been in business for over 60 years and have 17 international offices on four continents.

What will the recruitment process look like?

• Application screening and brief feedback via email or through the recruitment platform.
• Selected candidates will be invited to a short phone interview with an HR Specialist.
• A Teams meeting with an HR Specialist/HR Manager and the Quality Assurance Manager or Global Quality Director (including a recruitment task).
• Second stage - a meeting with the Global IT Department (Global IT Director and Team Leader CSV).
• Third stage - an on-site meeting at our office with the HR Manager and Department Manager to discuss employment details.
• If everything goes well - and we believe it will! - we will be delighted to begin our cooperation with a probationary period.