Data Integrity Consultant

Trevalco; Antwerpen; Sur place; EUR 45 000 - 65 000; Plein temps

Résumé du poste

Trevalco is seeking a data integrity consultant to join our pharmaceutical client projects. You will assess systems for compliance with 21CFR Part 11, Eudralex annex 11, and internal requirements, identify gaps, and draft action plans.

The role requires English and Dutch fluency, strong analytical skills, and experience in ICT quality assurance within pharma. You will work independently, balance quality, budget, and schedule, and support risk assessments and quality investigations.

Qualifications

• Fluent in English and 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
• 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 clearly and enthusiastically

Responsabilités

• execute data integrity compliance / gap assessments
• 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

Connaissances

Fluent in English and Dutch

Strong analytical skills

Well organized

Studious and precise

Independent worker

Formation

Master's degree in science/IT/engineering

Equivalent through experience

Outils

ALCOA knowledge

GAMP knowledge

Description du poste

Data integrity remains a hot topic in the pharmaceutical industry. 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, although a first experience in the pharmaceutical industry is required.

Your responsibilities as data integrity consultant include:

• execute data integrity compliance / gap assessments
• 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

Must have qualifications

• fluent in English and 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

Very nice to have qualifications

• experience working in a pharmaceutical GxP environment
• experience in CSV
• knowledge of ALCOA, Part 11, EU annex 11 or GAMP