Qa/Qs Officer (It)

Do you have a technical background, experience in computer system validation and do you have an effective work approach? Then we are eager to learn more about you as a candidate!

For our manufacturing site we are currently recruiting a: QA/QS Officer (IT)

Purpose of the role

Assuring quality from an IT perspective…if you are able to explain that effectively to someone who is unfamiliar with the topic, then we might be looking for you!

In this specialized, but important, role you will be working on the validation of GMP computerized systems for our manufacturing site in Oss, The Netherlands. Your two main fields of responsibility will be on the one hand to ensure compliance with local legislation and on the other hand to ensure compliance with our company IT policies.

Tasks and responsibilities

• Collaborating with stakeholders to assess and select computerized systems to support GMP business processes;
• Providing the independent quality approval of key qualification/validation documentations.
• Assuring site/above site system owners have Operating Level Procedures/Plans, approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status;
• Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective;
• Supporting regulatory inspection and audit activities as needed;
• Driving resolution of regulatory non-conformance for GMP computerized systems;
• Monitoring and communicating system health, compliance and other metrics updates to key stakeholders;
• Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process, improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices;
• Representing Technical Quality Assurance management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues;
• Contribute to the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systems.

Your profile

• Bachelor in IT, chemical engineering, pharmaceutical studies or another related field of study;
• At least 4 to 5 years of relevant work experience (e.g.: validated IT solutions or application support);
• You have a good understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations;
• You have a sufficient knowledge of the principles, theories and concepts of computerized system validation and compliance.
• You have a good understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), local regulatory expectations and GMP;
• Ability to work both independently and in a team, collaboration skills, pragmatic, communication skills (oral and written), analytical skills and problem solving skills.
• Listening skills, project management skills and able to handle changing priorities.
• Sufficient language skills in English and Dutch are a must.

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect:

• Competitive salary and a 3% year-end bonus;
• 35,5 days of leave and the possibility to buy even extra days;
• Attractive collective health care insurance package with considerable reduction rates;
• Solid Pension plan;
• Incentive plan;
• Travel allowance for commuting;
• Partially remote work/hybrid working policy;
• Numerous training, coaching and e-learning modules for long term job opportunities and development.