Experienced Compliance Specialist for Pharmaceutical production

Experienced Compliance Specialist for Pharmaceutical production
Maintenance

Do you want to develop and lead technical compliance in a strong team in pharmaceutical production? Are you able to manage GMP, and do you want to work with classic unit operations? And do you also thrive teaching others and having many contacts in the organization?

Xellia Pharmaceuticals is a specialty pharmaceutical company focused on providing important anti-infective treatments against serious and often life-threatening infections. In Xellia, our purpose is to save lives by producing special antibiotics.

Welcome to Engineering & Maintenance
We have projects and exciting assignments for an experienced specialist with the desire to combine technical expertise with quality and secure our 'license to operate'.

Together with three other colleagues, you will need to define, improve, and maintain the right quality level for our utility systems. You will set the framework and work across Engineering & Maintenance and the rest of Xellia. In addition, you will work with our QA, production, and support departments to convert input into documentation.

More specifically, this means you need to:

• lead technical compliance, spare with colleagues about GMP compliance for e.g.
  
  
• ventilation, cooling, and water systems as well as monitor steam and compressed air
  
  
• conduct and coordinate troubleshooting of process equipment with systematic problem-solving
  
  
• improve and maintain our technical documentation to maintain the right level of compliance
  
  
• handle deviations and changes, so we are compliant with our utility supply and production facilities
  
  
• present facilities and documentation related to customer audits and regulatory inspections
  
  
• develop and improve day-to-day workflows
  
  
• be the mentor of the next generation of compliance specialists.
  
  

Do your best with us
You will be part of a team where we are currently 10 colleagues ready to welcome you. We focus on job satisfaction and shared success. Together we are responsible for the technical documentation for our facility in Copenhagen. We focus on supporting our colleagues in Engineering & Maintenance and sharing our knowledge and collaboration across the organization, so everyone can do their best.

We imagine that you:

• have the courage to work and develop your and your colleagues' talent within Technical compliance
  
  
• have a technical or analytical engineering background or similar
  
  
• can create results and know what it takes to take control in both critical situations and long-term planning
  
  
• can translate technical languages into the necessary documentation and communicate in both Danish and English
  
  

We value these skills because you need to work with technicians, engineers, pharmacists, and managers across the organization. The position requires you to be outgoing and comfortable in a role where you are responsible for both customers, partners, and colleagues.

Are you our new colleague?
If you would like to know more about the tasks, please contact Rasmus Friche at +45 4173 1603. Interviews will be held on an ongoing basis, so apply for the job as soon as possible and no later than December 28 2022.

We look forward to welcoming you.

Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company’s evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.
Further information about Xellia can be found at: www.xellia.com
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