Data Integrity Specialist
Il y a 2 jours
Geel, VLG, Belgique
Amaris Consulting
Télétravail
Temps plein
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Join Amaris Consulting and contribute to data integrity and compliance projects within the pharmaceutical industry. You will support a key pharmaceutical client in reviewing GxP-regulated analytical equipment and associated computerized systems across Manufacturing and Quality Control (QC).
Working alongside site Subject Matter Experts and under the supervision of an experienced project leader, you will help ensure data reliability, traceability, and compliance with pharmaceutical quality requirements.
# Your Missions
- Perform Data Integrity compliance reviews of GxP-regulated analytical equipment and associated computerized systems.
- Conduct gap assessments, data flow mappings (digital or hybrid), and Data Integrity Risk Assessments.
- Verify equipment interfaces to ensure the completeness and accuracy of data generation and transfer.
- Review audit trails, data traceability, electronic data management, and system access controls.
- Assess IT security measures and equipment controls to identify potential Data Integrity gaps.
- Document findings, identify compliance gaps, and contribute to remediation proposals.
- Create, update, and review documentation in accordance with established protocols and standardized templates.
- Collaborate with site Subject Matter Experts and cross-functional teams to support compliant and reliable data management practices. #
Your Profile
- 1–3 years of relevant experience in a highly regulated environment, preferably within the pharmaceutical industry.
- Familiarity with GxP requirements for analytical equipment in Manufacturing and/or Quality Control environments.
- Strong knowledge of Data Integrity principles, particularly ALCOA++.
- Understanding of data flows, audit trails, traceability, system access management, and computerized system controls.
- Knowledge of risk management and risk-based approaches, such as ICH Q9.
- Strong analytical skills and a high level of attention to detail.
- Ability to work independently within a structured protocol and follow standardized procedures.
- Good communication skills and the ability to collaborate effectively with cross-functional teams.
- A proactive mindset, with a strong commitment to quality, compliance, and continuous improvement. #
What We Offer
Joining Amaris isn’t about joining a company where you simply wait patiently for a vacancy to arise. It’s about becoming part of an environment where your performance directly drives your career progression. Projects worth your time 18+ months on average, with major accounts (Orange, Sanofi, SNCF, CMA-CGM…) and the support of our internal Centers of Excellence. You get the depth, not just the breadth. Real management support 1 manager for up to 18 consultants, structured project check-ins, and a direct line to HR every month through Express Yourself. Our teams average 3.3 years of tenure — proof that we build something that lasts. A career that actually moves 70% of our managers started at entry level. Average age: 36. Here, trust comes before experience and merit drives progression — not seniority. Functional (4 areas of expertise) and geographic (60+ countries) mobility are actively encouraged. Innovation, in practice 291 AI agents built in-house, 250+ training modules, Microsoft certifications fully funded. At Mantu, AI stands for Artificial Intelligence — and Augmented Impact. CSR with real targets SBTi carbon reduction roadmap, 32% women in management (target: 34.3% by 2029), social engagement through We Care Together. Health insurance, remote work, meal vouchers, time savings account, referral bonus… We’ll talk about our full benefits package during our interviews. *Mantu is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
* ## Who are we? Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success. At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like: Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you Interviews (the average number of interviews is 3
- the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc. As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience. We look forward to meeting you
- Perform Data Integrity compliance reviews of GxP-regulated analytical equipment and associated computerized systems.
- Conduct gap assessments, data flow mappings (digital or hybrid), and Data Integrity Risk Assessments.
- Verify equipment interfaces to ensure the completeness and accuracy of data generation and transfer.
- Review audit trails, data traceability, electronic data management, and system access controls.
- Assess IT security measures and equipment controls to identify potential Data Integrity gaps.
- Document findings, identify compliance gaps, and contribute to remediation proposals.
- Create, update, and review documentation in accordance with established protocols and standardized templates.
- Collaborate with site Subject Matter Experts and cross-functional teams to support compliant and reliable data management practices. #
Your Profile
- 1–3 years of relevant experience in a highly regulated environment, preferably within the pharmaceutical industry.
- Familiarity with GxP requirements for analytical equipment in Manufacturing and/or Quality Control environments.
- Strong knowledge of Data Integrity principles, particularly ALCOA++.
- Understanding of data flows, audit trails, traceability, system access management, and computerized system controls.
- Knowledge of risk management and risk-based approaches, such as ICH Q9.
- Strong analytical skills and a high level of attention to detail.
- Ability to work independently within a structured protocol and follow standardized procedures.
- Good communication skills and the ability to collaborate effectively with cross-functional teams.
- A proactive mindset, with a strong commitment to quality, compliance, and continuous improvement. #
What We Offer
Joining Amaris isn’t about joining a company where you simply wait patiently for a vacancy to arise. It’s about becoming part of an environment where your performance directly drives your career progression. Projects worth your time 18+ months on average, with major accounts (Orange, Sanofi, SNCF, CMA-CGM…) and the support of our internal Centers of Excellence. You get the depth, not just the breadth. Real management support 1 manager for up to 18 consultants, structured project check-ins, and a direct line to HR every month through Express Yourself. Our teams average 3.3 years of tenure — proof that we build something that lasts. A career that actually moves 70% of our managers started at entry level. Average age: 36. Here, trust comes before experience and merit drives progression — not seniority. Functional (4 areas of expertise) and geographic (60+ countries) mobility are actively encouraged. Innovation, in practice 291 AI agents built in-house, 250+ training modules, Microsoft certifications fully funded. At Mantu, AI stands for Artificial Intelligence — and Augmented Impact. CSR with real targets SBTi carbon reduction roadmap, 32% women in management (target: 34.3% by 2029), social engagement through We Care Together. Health insurance, remote work, meal vouchers, time savings account, referral bonus… We’ll talk about our full benefits package during our interviews. *Mantu is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
* ## Who are we? Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success. At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like: Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you Interviews (the average number of interviews is 3
- the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc. As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience. We look forward to meeting you