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Specialist, Regulatory Affairs (Temporary Position)

As Regulatory Affairs Specialist, you will be responsible for lifecycle management of products manufactured at Orifarm’s own manufacturing sites. Therefore, you will collaborate closely with colleagues across functions, such as chemists, formulation specialists and co-workers within Quality, Supply Chain, Manufacturing and Sales.

Further, your main responsibilities include to:

• Gather information and documentation for variation applications
• Update dossier sections

Senior Specialist til QC hos Xellia Pharmaceuticals

Drømmer du om mere ansvar, med forskelligartede opgaver, og har du en passion for mikrobiologi? Vil du spille en central rolle i Xellias produktionen af livsvigtig antibiotika?

Som senior specialist vil du blive faglig ansvarlig for vores count release-laboratorie, som bl.a. udfører TVC- og LAL-analyser. Derudover vil du indgå i tæt samarbejde med vores sterile produktioner angående EM, hvor de nye Annex 1-krav stiller øgede krav til vores compliance, som du vil spille en vigtig rolle i.

QA Specialist og Senior QA Specialist

For dig, der trives med at arbejde med kvalitet og lovgivning fra et operationelt perspektiv, både selvstændigt og i dialog med vores leverandører og interne afdelinger.

Som QA Specialist vil du være det koordinerende bindeled mellem de forskellige teams i QA, regulatorisk og Pharmacovigilance i relation til udfærdigelse eller opdatering af eksisterende TA.

MS&T Program Manager

We are looking for an experienced professional from the pharmaceutical industry, who can effectively manage project plans across multiple entities and lead cross-functional processes within our own sites and supply chain.

As a MS&T Program Manager, you will be responsible for managing the projects, maintaining project databases, as well as ensuring effective communication and timely achievement of milestones.

Manufacturing Science & Technology (MS&T) Technical Transfer Project Manager (Sr Specialist)

Join Orifarm and take charge of building strong business relationships with a key portfolio of our suppliers!

As a MS&T Technical Transfer Project Manager, you will be responsible for securing technical support to Supplier Relationship Management functions, and manufacturing sites comprising support, technological transfers between CMOs and own manufacturing sites, analytical method development and validation, external product development at CDMOs and driving continuous technological improvement and innovation.

QA Team Manager

Er du passioneret omkring ledelse og udvikling, og kan du overføre glæden til et team af dedikerede specialister? Har du derudover erfaring indenfor QA og GMP, så har vi en interessant mulighed i vores Life cycle management og release afdeling.

I rollen som Team Manager bliver det din opgave at supportere et inkluderende miljø og fordre effektivt samarbejde i teamet af dygtige QA-medarbejdere. Derfor er det vigtigt, at du evner at specificere opgaver klart og tydeligt, definere mål og prioriteter, samt at du kan kommunikere og uddelegere ansvar i dit team.