Senior consultant/auditor – Pharma QA

Pharma QA
Lund, Stockholm
Flexible remote working

Our team is growing, and we are looking for talented senior QA consultants and auditors to join us in working to meet our clients’ needs. Your skills will be part of what Key2Compliance offer our customers. You will be part of our team of both experts and generalists who help companies in the pharma industry. Together, we can give our clients the most qualified support available.

Since 1994, we have helped companies develop safe products for patients all over the world. Join our team of highly engaged co-workers, in a great atmosphere with every opportunity to grow and develop.

About the role

As a senior consultant/auditor in the Pharma QA team you will be part of our team of specialists that work with a wide variety of clients and products in the pharma industry. You will manage your own projects in dialogue with the client and often work in teams with colleagues from the Pharma QA team and our other teams; Clinical Development, Biological Safety and Medical Device QA/RA. The assignments can often be managed from our office or from home, but at times require us to be on site. The assignments vary from short-term expert support projects to longer part- or full-time assignments, giving you an interesting variety in your daily work.

If you enjoy teaching, there is also a possibility to assist the Training & Courses team with giving courses in e.g., GMP, GCP or GDP.

About You

We believe that you, to be successful in the role, have several years of experience from quality assurance and auditing in the pharma industry, within one or several of the GMP/GCP/GDP areas. We believe that you are highly interested in learning new things and enjoy working with several clients simultaneously. You are organized and analytic, enjoy problem solving and thrive off challenges. You are pragmatic and solution oriented with the best for the patient in mind. You have strong communication skills both in Swedish and English, are service minded and believe that teamwork and sharing knowledge leads to the best results.

Key duties

You will support our clients as a senior QA consultant and auditor, with the issues they have at hand. Assignments vary and may include to:

  • Carry out internal audits
  • Conduct audits of suppliers, vendors or contract manufacturers
  • Carry out GAP analyzes
  • Create customer customized QMS
  • Act as Quality Manager in short or long assignments
  • Support in validation-, risk management- or improvement projects
  • Act as senior QA advisor

Qualifications

Education Requirements/Certifications

  • Ph.D. or Master’s degree in Life Sciences
  • Certified auditor
  • Documented advanced training in GMP, GCP or GDP

Required knowledge/skill

  • Full professional written and oral communication skills in English and Swedish, Danish is a plus
  • Senior level understanding of requirements in the pharmceutical industry. EU and FDA

Experience Required

  • At least 10 years’ experience of pharma quality assurance in leading positions
  • Thorough experience of GMP, GCP or GDP auditing

Information and contact details

Place of employment: Stockholm or Lund, Sweden

Scope: Full time

Questions: Please contact Director Pharma QA Charlotta Hjerpe, charlotta.hjerpe@key2compliance.com

Other: We screen the applications and hold interviews continuously so please send your application as soon as possible.

We look forward to receiving your application!

Read more about us here!

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