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CSV Data Integrity Lead

TMC -
Bruxelles

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Détails de l'emploi

Il y a 1 jour

Qualifications

Systèmes de dossier médical électronique
Production
Néerlandais
Réglementation FDA

Description complète du poste

Belgium Life Sciences 5 - 10 years Brussels Hybrid

Take ownership of CSV & Data Integrity and drive compliance, improvement and impact in a highly regulated pharma manufacturing environment with a client.

About The Member Company

We are a global high-tech consultancy company with a team of entrepreneurial engineers, scientists, and digital experts from around the world. Together we form a fast-growing and proud community. We offer consultancy services to high-profile clients globally in diverse service areas, such as:

Technology & Engineering
Energy & Renewables
Life sciences & Pharma
Digital & IT

About this vacancy

As LPO & GET Lead for Computer System Validation (CSV) & Data Integrity (DI), you are the site-wide process owner and subject matter expert for all CSV/DI activities within the GET organization, with a client. You ensure compliant, robust and future-proof processes while driving continuous improvement across departments. You also play a key role in audits, inspections and regulatory readiness. On-site presence: minimum 60%. Your impact: Own and improve site-wide CSV & DI processes and procedures Drive remediation and compliance uplift plans across GET departments Maintain SOPs, training materials and ensure inspection readiness Act as SME during internal and external audits Collaborate with global process owners and QA partners Share best practices across communities of practice Strengthen end-to-end compliance and data integrity mindset

What we expect from you

Strong expertise in CSV & Data Integrity in pharma manufacturing Knowledge of 21 CFR Part 11, EU Annex 11, GAMP Experience with systems like DeltaV, PI, PCS7 is a plus Strong understanding of FDA/EMA expectations Experience with risk-based validation and documentation Project and stakeholder management skills Ability to influence, coach and drive change Fluent English, Dutch is a plus

What you can expect from us

TMC is an international high-tech consultancy company that brings expertise to its clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients and we help them to be more competitive in an ever more global and faster-changing technological world. At TMC we believe that people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive in. We offer you a challenging and stimulating work environment in which you can be the director of your own career. As an Employeneur you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture. ##LI-EW1

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