Regulatory Compliance Specialist, Pharmaceutical Production Support

3 days ago


Copenhagen, Copenhagen, Denmark Lundbeck Full time
Job Description

Lundbeck is seeking a highly skilled Regulatory Compliance Specialist to join our Pharmaceutical Production Support team. As a key member of our production support team, you will be responsible for ensuring high levels of quality and compliance in our area.

The ideal candidate will have +3 years of relevant working experience within GxP and excellent collaboration skills with an analytical mindset. You should also have experience within Operational Excellence/LEAN and be fluent in Danish and English, both written and oral.

Your Key Responsibilities:

  • Provide first line GMP support to production.
  • Participate in complex - and high impact projects and help guide our stakeholders in the right direction.
  • Ensure a high level of quality and compliance in our area by working with a quality - and continuous improvement mindset.
  • Create and review quality-related documents such as SOPs, deviations, complaints, and change requests.
  • Participate in relevant authority inspections and internal audits.

About the Role:

This is a dynamic and independent job with skilled and fun colleagues. You will work closely with the team to identify improvement potentials and participate in relevant authority inspections and internal audits.

What We Offer:

We offer a competitive salary range of $65,000-$85,000 per year, depending on your qualifications and experience. Additionally, we provide opportunities for professional growth and development, a collaborative and supportive work environment, and a comprehensive benefits package.

Requirements:

  • An academic degree (e.g., Pharmaceutical Sciences, Engineering)
  • +3 years of relevant working experience within GxP
  • Excellent collaboration skills and analytical mindset (data-based approach)
  • Experience within Operational Excellence / LEAN
  • Fluent in Danish and English, both written and oral

How to Apply:

If you are a motivated and detail-oriented individual with a passion for regulatory compliance, please submit your application, including your CV and a few lines about your motivation for applying. We look forward to hearing from you.



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