Job position: data integrity consultant
Data integrity is a hot topic in the pharmaceutical industry for the past 20 years. Pharmaceutical companies rely on consultants to provide the necessary knowledge and insights to ensure that their systems comply with the latest regulatory requirements. A job as data integrity consultant requires detailed knowledge of the applicable regulations, good skills in technical analysis and a capability to collect information from different sources (people, archives, systems).
As data integrity consultant you execute assessments on systems to evaluate whether they meet the requirements of 21CFR Part 11, Eudralex annex 11 or internal requirements of the pharmaceutical client. You identify items of non-compliance or improvement, you draw up action plans and are involved in the execution of projects to improve the overall compliance in the company.
For this position we are looking at different levels of experience, altough a first experience in the pharmaceutical industry or in an ICT QA position is required.
Your responsibilities as data integrity consultant include:
- execute data integrity compliance / gap assessments
- define action plans (e.g. CAPA)
- write technical reports
- participate to improvement projects
- manage quality records such as deviations, CAPA's and change controls
- participate to risk assessments and quality investigations
- ensure compliance to and advice the client on regulatory requirements, industry trends related to data integrity
- take decisions which properly balance out quality / budget / planning and help stakeholders to reach a compromise on critical quality decisions
- fluent in English, at least conversational level in Dutch
- strong analytical skills, well organized, studious and precise
- a first experience in an ICT quality assurance position or a similar position in the pharmaceutical industry
- you are patient with people, capable of gaining their trust and collecting the information needed to complete your work
- you can work independently and capable of standing your ground when challenged
- commercial attitude, able to convince clients by communicating in a clear and enthusiastic way
- master degree in science, information technology or engineering, or equivalent through experience
Nice to have
- experience working in a pharmaceutical GxP environment
- experience in CSV
- knowledge of ALCOA, Part 11, EU annex 11 or GAMP