CQA Specialist - Benelux

Vantive; Eigenbrakel; Sur place; EUR 62 000 - 90 000; Plein temps

Résumé du poste

Vantive seeks a CQA Specialist to ensure compliance across regulatory licenses (WDA & MIA) and quality systems within the Benelux. You will coordinate with Regulatory Affairs, Pharmacovigilance and logistics to maintain certifications such as ISO 9001 and ISO 13485.

You will lead post-market surveillance, support quality initiatives, and act as a back-up Responsible Person. Fluency in Dutch or French and English, along with GMP/GDP knowledge, are essential.

Qualifications

• Master degree in pharmaceutical sciences, medicine, chemistry, biology, biomedical sciences or bio engineering.
• Eligible as Responsible Person.
• Experience in quality in pharma/medical devices preferred.
• Fluency in Dutch or French, and working proficiency in the other language and English.
• Office basic knowledge.
• Knowledge of GDP and GMP standards and quality systems.
• Product and process validation methodology.
• Knowledge of Medical Industry Processes.
• IT functional knowledge (ERP, data management).
• Strong interpersonal and communication skills.
• Organizational and project management skills.
• Self-motivation and commitments.
• Trackwise, JDE, ERP systems knowledge is a plus.
• ISO Certification knowledge is appreciated.

Responsabilités

• Maintain related regulatory licenses (WDA & MIA).
• Ensure outsourced storage and distribution comply with European and local requirements and implement quality systems.
• Act as the Post Market Surveillance and local contact for medical devices.
• Provide Quality Support to local business initiatives with Quality Operations.
• Maintain contacts with Regulatory Affairs, Pharmacovigilance, 3PL, transporters and businesses.
• Responsible Person Back-up.

Connaissances

Fluency in Dutch or French

English proficiency

Office basic

GDP/GMP knowledge

Product/Process validation

Medical industry knowledge

IT functional knowledge

Interpersonal skills

Organizational/Project mgmt

Self-motivation

Trackwise/JDE/ERP familiarity

ISO Certification knowledge

Formation

Master Degree in Pharmaceutical Sciences or related

Outils

ERP systems

JDE

Trackwise

Description du poste

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your Role at Vantive

This is where your motivation addresses challenges

You are accurate. You have an eagle eye, a sharp critical thinking and the willingness to learn, develop and improve. You embrace a challenge and truly apply the collaborative powers of the team to produce excellent results. You are motivated by work that is never the same from one day to the next. You can absorb and act on complex procedures and data and train the team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

Your Team at Vantive

As a CQA Specialist, you will report directly to the CQA/RA Manager Benelux. The Quality function values both working together as a team and independently. We draw energy from working in collaboration with internal and external stakeholders. As the company evolves, so does the way our team approaches work as it strives to create new development opportunities and new ways of working.

What you will be doing

• Responsible for maintenance of related regulatory licenses (WDA & MIA).
• Responsible for ensuring outsourced storage and distribution activities are in line with European and local legal requirements, and Corporate Quality Systems implementation in the Benelux local entities to ensure establishment and maintenance of required licenses (e.g. WDA, MIA, ISO 9001 and ISO 13485 certifications).
• Act as the Post Market Surveillance and local contact person for medical devices.
• Responsible for Quality Support to local business initiatives in collaboration with Quality Operations.
• Ensuring that appropriate contacts with country Regulatory Affairs, Pharmacovigilance, third-party logistics (3PL) for Warehouse & Distribution (W&D), transporters and Businesses are maintained.
• Responsible Person Back-up.

What you will bring

• Master Degree in Pharmaceutical Sciences, Medicine, Chemistry, Biology, Biomedical Sciences or Bio Engineering. Eligible as Responsible Person.
• Preferable prior work experience in quality or equivalent experience within a pharmaceutical/medical device company, CRO or similar organization.
• Fluency in Dutch or French, and working proficiency in the other national language and English (written and spoken).
• Office basic knowledge required.
• Knowledge of GDP and GMP standards and applicable quality systems in area of responsibility.
• Product and process validation methodology.
• Knowledge of Medical Industry Processes.
• IT functional knowledge (ERP systems, data management systems).
• Good interpersonal and communication skills: ability to collaborate closely with different functions involved and with multicultural teams.
• Organizational and project management skills.
• Self-motivation and commitments.

• Trackwise, JDE, ERP system particular knowledge is a plus.
• ISO Certification knowledge is appreciated.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process,

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