Quality Assurance CSV Automation EngineerMedior (Petro) chemie
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. Do you want an indirect contribution to public health by improving the production process of medicines? Then read on and respond quickly.
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?
- A great job with one of our prominent clients
- Good salary conditions, career opportunities and excellent benefits.
- Conversion to the client after a period of secondment when performing to client satisfaction
- Our nice extras: discount on your health insurance premium, Referral bonuses, other activities (e.g. soccer tournament, Christmas reception etc.)
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 life cycle.
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.