Senior QA Specialist

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Søborg

Senior QA Specialist to highly well-functioning team


Do you want major responsibility and great variety in tasks?


If you have a quality mindset backed by GMP experience and you are looking for an opportunity to use all of your skills in a role with a broad responsibility, you do not have to look any further. At Ferrosan Medical Devices you can look forward to being involved in daily operation as well as various projects. You will create tangible results and make a valuable difference together with multiple people across functions, internally as well as with our external partner and contract manufacturers.

QA tasks, exciting projects and collaboration with multiple contacts


As part of a small company with R&D and production at the same site, you will have a broad and exciting responsibility. You will have the opportunity to work closely with our production, our external contract manufacturers and become QA’s representative in various compliance, improvement and development projects. The projects will focus on product development, optimization of our production and ensuring compliance. Your primary tasks cover:

  • Deviation, CAPAs and Change records
  • Qualification and validation documentation
  • Risk management and risk analysis
  • Quality oversight of CMOs and Sterilization sites
  • Quality Supplier Management
  • Optimization of the Quality Management System
  • Ensure compliance in various projects

There will be a great variety in QA tasks. You will have the opportunity to participate in auditing and self-inspection, mostly as support to the team’s Lead Auditor and colleagues with specific audit expertise.

You will support the organisation as a quality expert and have an important role ensuring compliance at Ferrosan Medical Devices so we continuously deliver world-class products used to stop bleeding during surgery.

Motivated team worker with 10+ years´ experience from a GMP environment


We are looking for a profile that wants to go home from work with knowledge of having made a difference that matters. If that person is you, you like to be trusted with responsibility, and you are ready to take decisions. Equally important is your pragmatic and collaborative approach – we can only succeed as a team across functions and departments. As you will have multiple contacts you will also need good communications skills including an ability to create a common understanding with people that do not have your expertise. Additionally, your CV comprises:

  • A Master of Science in pharmacy or related
  • 10+ years´ experience as QA from a GMP environment and/or ISO 13485 and 21 CFR Part 820
  • Experience working as QA’s representative in various projects
  • Experience working with external partners, CMOs and sterilization sites is an advantage but not a prerequisite for applying
  • Ability to work with systematic problem solving and LEAN principles.
  • Fluency in Danish and English, written and spoken

QA – your new department


You will join 11 skilled and dedicated colleagues counting 7 QA Specialists, a Lead Auditor and 3 Technicians. Together, we contribute all the way from first receipt of raw materials to the finished products is released to the market. Our environment is very welcoming and characterised by team spirit and helpfulness, also in busy times. We believe that people that support each other and have a good time together create the best results.

Contact and application


Please mark your application “Senior QA Specialist” and send it with your CV here . The deadline is 2nd December 2020. If you have any questions, you are welcome to contact QA Manager Naja Kundby at 7025 2860.

We are looking forward to receiving your application.

I Ferrosan Medical Devices udvikler og producerer vi produkter, der anvendes til at stoppe blødninger ved operationer. Og vi er gode til det. Faktisk så gode, at vores produkter er bredt anerkendt som blandt de bedste i verden. Det får os dog ikke til at læne os tilbage og nyde succesen. Vi vil videre, og du kan komme med. Hos os får du mulighed for at opleve, hvordan dine ideer fungerer i den virkelige verden – fordi vi i Søborg har samlet alle funktioner under samme tag, fra R&D til produktion. Du vil hurtigt finde ud af, at du er kommet til et sted, hvor du bliver mødt med ægte interesse for, hvem du er som menneske. Mangler du hjælp, kan du være sikker på at finde den. Har du en god idé, kan du være lige så sikker på, at der bliver lyttet. Hos os er der hverken nulfejlskultur eller skjulte agendaer. Vi er ca. 230 gode kolleger. Skal du være den næste, så glæder vi os til at høre fra dig.   


Information og data

Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".

Arbejdsstedet er beliggende i Søborg.

Jobbet er oprettet på vores service den 16.11.2020, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Produktspecialist
  • Søborg
Rapportér

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