Quality Assurance CSV Automation EngineerMedior Food / Pharma / Life Sciences
Our client is a worldwide player in healthcare and is a manufacturer of medical supplies and vaccines and with that has a big impact on a healthier world. The products and services of our client make innovative treatments possible for human and animal around the world.
Wat verwachten we van jou?
- BSc in Information Technology, Engineering or comparable;
- You bring hands-on experience and have an understanding of automated systems supporting pharma manufacturing, IT infrastructure or Laboratory operations;
- You have knowledge of Automation and writing CSV documents;
- You have experience in Application support or delivering validates IT solutions;
- You have an understanding of pharmaceutical industry and its regulations (FDA/EU/ICH) with emphasis in 21 CFR (Code of federal regulations) (parts: 11, 210, 211 & 820) and also local regulations;
- Must: Working knowledge of principles, theory and concepts of computerized system validation;
- Familiar with: implementation of Quality systems in Pharmaceutical, Laboratory or Biotechnological manufacturing;
- Proficient communicative skills (spoken and written) in English are mandatory, Dutch a big pre.
Wat kun jij verwachten?
- You will earn a competitive salary;
- Opportunities for professional and personal development;
- Discount on your health insurance;
- Referral bonuses and other activities;
- Conversion to the client after a period of secondment when performing to client satisfaction.
You collaborate with stakeholders to asses and select computerized systems to support GMP business processes. This is to make sure the selected technologies meet the high-level needs and ensure the initial project is a match to the complexity and risks of the work. You provide quality approval of key qualification and validation documentation related to changes (e.g. Policies, procedures, protocols, requirements etc) to ensure compliance to company standards and applicable regulations throughout computerized system lifecycle.
You make sure all stakeholders have approved plans and procedures in place to ensure the computerized systems status is always validated. You review processes and support documentary evidence to verify compliance activities related to the systems are effective. You support regulatory inspections and audits as prescribed. You drive resolution of non-conformance to regulations for GMP in the computerized systems.
You monitor and communicate regarding system health, compliance and updates to key stakeholders. You promote GMP awareness and continuous improvement within the departments. You represent the QA IT management on site and in system specific meetings. You contribute to the development and maintenance of training programs.