Industrial Pharmacist & Regulatory Affairs Officer

English

Air Liquide Medical Ltd. NV and Air Liquide Healthcare Netherlands provide healthcare professionals and patients with solutions that contribute to our mission of protecting vulnerable lives. We are constantly inventing and developing solutions for healthcare facilities. In the Hospital Care (Belux) business, our employees serve more than 7,500 hospitals and clinics every day, supplying them with oxygen and other medical gases. In the Homecare business (Belux), our employees take care of the respiratory treatment at home of, among others, more than 40,000 patients.

French

Air Liquide Medical SA et Air Liquide Healthcare Pays-Bas fournissent aux professionnels de la santé et aux patients des traitements des solutions qui contribuent à notre mission de protection des vies vulnérables. Nous inventons et développons en permanence des solutions pour les établissements de santé. Dans l’activité Soins hospitaliers (Belux), nos employés servent chaque jour plus de 7 500 hôpitaux et cliniques, en les approvisionnant en oxygène et autres gaz médicaux. Dans l’activité Soins à domicile (Belux), nos employés s’occupent du traitement respiratoire à domicile ,entre autres, de plus de 40.000 patients.

Dutch

Air Liquide Medical NV en Air Liquide Healthcare Nederland voorzien professionals in de gezondheidszorg en patiënten van oplossingen die bijdragen aan onze missie om kwetsbare levens te beschermen. Wij zijn voortdurend bezig met het uitvinden en ontwikkelen van oplossingen voor zorginstellingen. In de sector Hospital Care (Belux) bedienen onze medewerkers dagelijks meer dan 7.500 ziekenhuizen en klinieken met de levering van zuurstof en andere medische gassen. In de Homecare-activiteit (Belux) zorgen onze medewerkers voor de ademhalingsbehandeling thuis van onder meer meer dan 40.000 patiënten.

(English)How will you CONTRIBUTE and GROW?

(French) Quelle sera votre contribution et comment vous épanouir dans ce poste ?

(Dutch) Hoe zal je bijdragen en groeien in deze functie?

Our Benelux Healthcare organization is looking for an Industrial Pharmacist - Regulatory Affairs Officer (with Belgian QP number - or the possibility to request one) to join its pharmaceutical-quality department. You will join a team of 10 people managing all the pharmaceutical and quality topics in the Benelux which means a great variety in your day to day tasks & projects.

Your job will consist of 3 parts:

1. Regulatory part

As Regulatory Affairs Officer , you are in charge of the different missions related to the regulatory affairs in Benelux by being supported by the corporate regulatory team.

Your responsibilities would include:

• Submission of the variations to our existing Marketing Authorizations

• Update of the SPC, leaflet, labels of each medicine

• Managing communication with Benelux authorities in relation to these topics

• Support the corporate team for the submission of new market authorisations

You work under the supervision of the Responsible for Information and Publicity (RIP), where you will be in charge of registration and verification of sponsoring and communication requests. When needed, you will submit a visum request to Mdeon (BE) or to Stichting CGR (NL).

2. Vigilance part

As Deputy LPO you manage the reception, registration and follow-up of the pharmaco- and materiovigilance cases.

You will work in close cooperation with the vigilance department of the corporate team and with its EU QPPV.

To achieve this, you ensure the implementation of a local management system for these cases:

• Follow up of pharmaco- and materiovigilance cases

• Regular training of concerned personnel

• Contact with authorities and manufacturers

3. GMP/GDP part

As Industrial Pharmacist :

• You guarantee compliance with GDP on HHC sites: in Benelux

• By performing monthly auto-inspections, you check authorized activities of reception, storage, transport and distribution of medicines and medical devices on these sites

• You manage non-conformities on site and implement corrective actions. You are fully involved in GDP inspection from belgian authorities

• You are back-up for the release of medicines on the different GMP sites
  

(English)Are you a MATCH?

(French)Etes-vous LA personne faite pour ce poste ?

(Dutch)Ben jij de juiste persoon voor deze functie?

Your profile:

• Industrial Pharmacist degree

• 0-3 years of experience

• Keen interest in the regulatory affairs

• Languages : French, Dutch, English

• Strong organization and communication skills

You will:

• report to the Pharmaceutical Affairs Director Benelux

• regularly be based in Zemst and Evere offices

• sometimes visit Schelle filling station

• rarely go to Lelystad offices (NL)

• monthly visit the Home Health Care distribution centers (2 in Flanders and 2 in Wallonia)

You will report to the Pharmaceutical Affairs Director Benelux.

(English)Our Differences make our Performance

At Air Liquide, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world.

We welcome and consider applications from all qualified applicants, regardless of their background. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world.

(French) Nos différences font notre performance

Chez Air Liquide, nous nous engageons à créer un environnement de travail collaboratif et inclusif qui reflète la diversité de nos collaborateurs, de nos clients, des patients et de nos parties prenantes ainsi que des cultures à travers le monde.

Nous accueillons et considérons les candidatures de tous les candidats qualifiés, quel que soit leur parcours. Nous sommes convaincus qu’une organisation diversifiée permet à nos collaborateurs de révéler leur talent, à la fois individuellement et collectivement, et qu’elle contribue à renforcer notre capacité d’innovation en faisant vivre nos fondamentaux, en agissant pour le succès/la réussite du Groupe et en créant un environnement engageant, dans un monde en mutation.

(Dutch) Onze verschillen maken onze prestaties

Bij Air Liquide zijn we toegewijd aan het creëren van een collaboratieve en inclusieve werkomgeving die de diversiteit van onze werknemers, klanten, patiënten en stakeholders, en culturen over de hele wereld weerspiegelt.

Wij verwelkomen en overwegen sollicitaties van alle gekwalificeerde kandidaten, ongeacht hun achtergrond. Wij geloven dat een diverse organisatie onze mensen in staat stelt hun talenten naar boven te brengen, zowel individueel als collectief, en helpt ons vermogen te versterken om te innoveren door onze grondbeginselen tot leven te brengen, te handelen voor het succes van de Groep en een boeiende omgeving te creëren in een veranderende wereld.