quality assurance/regulatory affairs manager

opslået
kontakt
liselotte jensen, randstad danmark
jobtype
fastansættelse
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jobdetaljer

opslået
lokation
københavn/frb., hovedstaden
jobkategorier
ingeniør & teknik
jobtype
fastansættelse
referencenummer
7662

kontaktinformationer

kontakt
Liselotte Jensen
telefonnummer
+45 92 92 11 40
e-mail
liselotte.jensen@randstad.dk

jobbeskrivelse


Do you want to take part in an exciting journey in a fast-growing pharmaceutical company in Denmark? Then please continue reading...

On behalf of Sana Pharma Medical, Randstad is recruiting a QA/RA Manager for their newly established office in Denmark. You will be a part of a team of 15 highly skilled colleagues in various sister companies in Norway, Sweden and Finland.

The QA/RA Manager will take on an important role in building and developing a new unit in Denmark. Furthermore, you will be responsible for Sana Pharma Medical’s regulatory activities performed in Denmark as well as their wholesaler activities. In this role, you will also be responsible for establishing and operating processes as well as making sure that procedures comply with all regulatory requirements and carrying out activities according to approval plans and budgets.

Your primary tasks and responsibilities will be to:

-Be responsible for wholesale.
-Be responsible for regulatory issues and quality assurance of all activities in Denmark.
-Maintain and develop Quality System (QS) in cooperation with headquarters in Norway.
-Assure that the medicinal products imported by Sana Pharma Medical comply with regulations and guide lines related to storage, handling and labeling of medicinal products.
-Participate in the regulatory responsibilities of being a Marketing Authorization Holder.
-Participate in developing new medicines for Denmark, Norway, Sweden and Finland.
-Ensure that all marketing materials comply with laws and regulations in the respective countries.
-Assist and execute tasks and assignments across companies and teams in the Medical Group.
-Ensure that all products meet the necessary quality standards.
-Participate in Pharmacovigilance and Medical Information work.

It is important that you thrive in an independent role and is passionate about building and developing a new department. It is important that you have a solid know-how and can maintain an overview in those situations where a solution is not given in advance.

Your profile

You hold a Master’s degree in pharmacy or another relevant subject. Furthermore, you have several years of experience in both Regulatory Affairs and QA from the pharmaceutical industry. As a person you are great at organizing, prioritizing and completing your tasks. Furthermore, you are not afraid to take responsibility in an environment that is constantly changing. You are self-motivating with a pragmatic attitude and approach to your daily work without compromising the quality.

This is an independent and challenging position in an international company. You will be working in an international environment where you will need your perseverance and to be detail-oriented. In return, you will have ample opportunities of professional and personal development. Being fluent in Danish and English, verbally and in writing, is a must.

Sana Pharma Medical

Sana Pharma Medical is a Nordic pharma company selling OTC pharmaceuticals, herbal medicine and medical devices through pharmacies. Sana Pharma Medical are focusing on high-quality management, certifications and constant development. Sana Pharma Medical are always challenging the established medical market, which has resulted in a fast-growing company.
Sana Pharma Medical has been nominated “Innovator of the year” by the biggest pharmacy chain in Norway and won prizes like “Launch of the year” in pharmacy chains like Boots and Lloyds in both Norway and Sweden.

About Randstad

Randstad DK is part of the international Randstad Group, which is the global leader in HR services. With more than 4,800 offices in 38 countries, we are providing work to more than 650,000 people every day.
In Denmark, we are among the leading temp and recruitment agencies with branches in Copenhagen, Aarhus, Aalborg, Kolding and Esbjerg. A position we have achieved due to our expertise in matching qualified candidates with the right job opportunities.