QA Specialist/Senior QA Specialist, GCP and GVP

 


KLIFO is looking for a QA Specialist/Senior QA Specialist, GCP and GVP

The position as QA Specialist/Senior QA Specialist:
We are a growing QA department where we need a new colleague with competencies regarding GCP and GVP. GLP experience will be a benefit. The job will be a mixture of internal and external QA activities.

The external activities can be:

  • QA consulting to Clients
  • Provide various QA services to Clients. E.g.:
    o Develop or update QMS system
    o GAP analysis
    o Help to become Inspection ready
  • Performing worldwide Client Audits

The internal tasks will mainly be:

  • Maintain the Quality Management System within the Clinical Area
  • Perform Training within the Clinical area
  • Ensure execution of the Clinical audit program
  • Participate in KLIFO projects as QA representative
  • Participate as QA representative in customer audits and inspections

Beside the above activities, be responsible for KLIFOs GDPR compliance review program.

The qualifications of the QA Specialist/Senior QA Specialist:
You are MSc in the life science field and the ideal candidate for the position is a trained lead auditor with at least 7 years of QA experience within GCP and GVP in the pharmaceutical industry. GLP QA and GLP auditing experience is considered a benefit.
You must be flexible and service-minded, a team player but also thrive working as a consultant and be capable of taking on a varity of different tasks and make decisions on your own.
Willingness to work from client sites, when required and to travel to the extend necessary.
Fluent in one of the Scandinavien languages and in English.

We offer:
Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
Join a team of experienced colleagues where you use and elaborate your skills and competences.
Work in an dynamic, flexible and positive working environment in a rapidly developing company.
You will experience a high-level of transparency and influence.

A flexible work schedule can be a possibility.

Location:
KLIFO has offices in both Denmark, Germany and Sweden. This position can be located at our office in Sweden or in Denmark.

Contact:
For more information, please contact Anne Ploug Jørgensen, Director, QA, mobile phone +45 44 222 982.

Applications should be sent to: moc.ofilk@boj marked QA Specialist/Senior QA Specialist GCP and GVP.
KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR). 

Deadline: Recruitment interviews will be held on an ongoing basis.

View job post as a PDF.

KLIFO is an established and integrated drug development consultancy with offices in Denmark, Germany, and Sweden. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement. For more information, visit www.klifo.com