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Regulatory and Quality Assurance Officer (M/F)

Publié le 17 novembre 2020

Référencezwauon9f1u

LocalisationLuxembourg

Domaine d'activitéSanté et esthétique

Type de contratCDI

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Description de l'entreprise

Sofitex Talent Recruitment
Fort d'une expérience de plus de 30 ans dans les Ressources Humaines, Sofitex est un réseau international de Travail Temporaire et de Placement en CDI. Sofitex fonde sa dynamique et son succès sur le professionnalisme de ses équipes, sa forte réactivité et sa proximité.

Description de l'offre

For one of our clients in the pharmaceutical sector located in Luxembourg city, Sofitex Talent is currently looking for a


Regulatory and Quality Assurance Officer (M/F)


- Contribute to the maintenance and development of the company's product regulatory dossier.


- Interface the company towards the regulatory authorities in various countries where our products are registered.


- Contribute to strengthen the company Quality structure and processes.


In the current COVID crisis situation, this role can be fulfilled for around 60% of the time from home, the remaining 40% requesting your presence in the office.


To this end, you will concentrate mainly on:


Regulatory Affairs (RA) – 45% of your time


o Keeping up to date with changes in regulatory legislation and guidelines mostly from EMA perspective.


o Compiling and maintaining regulatory documentation databases for all RA activities.


o Coordinate efforts associated with the preparation of regulatory documents or submissions.


o Maintaining familiarity with company product portfolio.


o Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review.


o Outlining requirements for labelling, storage and packaging.


o Communicate with EMVO (European Medicines Verification Organisation) and national MVOs regarding serialization.


o Ensuring the company, as MAH, complies with all its obligations with regards to applicable regulations.





Quality Assurance – 35% of your time


o Preparing and implementing quality assurance policies and procedures (SOPs).


o Conducting regular trainings for employees for Quality related SOPs.


o Ensuring that standards and safety regulations are observed in our contract manufacturing partners (ex: audits and quality agreements).


o Addressing and discussing quality issues and proposed solutions.


o Documenting quality assurance activities such as change control, deviations, PQRs,…


o Planning, undertaking and overseeing quality inspections which can be by external  partners, authorities, or internal audits.


The rest of your time (20%), will be dedicated to documentation and archiving management for the company.

Profil recherché

- You are holder of a university degree such as chemistry, biochemistry, biotechnology,pharmacy, medicinal chemistry, biomedical science, life or applied science


- You have at least 2 years of experience in pharmaceutical industry.


- English is a must, French and/or any other language is a plus.


- Good knowledge of software packages including Microsoft Office Suite (especially Excel and PowerPoint).


- High degree of autonomy and anticipation, ability to set up priorities and follow on deadlines.


- Very well organized, accurate to your daily work and reliable.


- You have a high degree of business ethics: High performance without ethics has,  for us, no value.


 This is an opportunity for a permanent contract to  to work in a lean, fast deciding company, start up mode, where you will be in the driving position to build the business.

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