GCP Auditor, Corporate Quality Audits
Ferring Pharmaceuticals A/S, Copenhagen, Denmark
QA / QC, Denmark.
Driven by research and a passion for science Ferring Pharmaceuticals is a biopharmaceutical company dedicated to the development of innovative treatments that make a real difference in people’s lives all over the world. Active in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopedics, we develop medicine on the body's own terms. We believe in the power of people and research - and go where ideas and research take us.
Corporate Quality Audits is part of Development QA in Ferring’s Global Quality Assurance (GQA) organization. Corporate Quality Audits is responsible for the global audit program covering GCP, GLP, GVP, GMP, GDP, Third Parties and Affiliates. The auditors are localized both centrally in the GQA organization in Copenhagen and locally in Ferring’s affiliates worldwide.
You will be a member of a highly motivated and dedicated team of auditors and your essential tasks will be to:
- Plan, conduct and report audits, mainly within GCP and GLP, covering Investigator Sites, Clinical Trial Reports, CROs, Ferring Internal GLP and GCP audits and Ferring affiliates performing clinical trial activities
- Report audit findings, trends and critical situations to Senior Management
- Interact with the Clinical Operation organization and compliance functions as part of follow up on audit observations and potential trends
- Actively participate in improvement initiatives driven by the organization
- Serve as GCP and auditing expert supporting protocol reviews, peer review and training
- Participate in preparation for Regulatory Inspections
- Write and update relevant SOPs in GQA
The job will include frequent travelling all around the world, approximately two monthly external audits.
The job is based in Copenhagen, Denmark.
We expect you to have an academic degree in a relevant science.
- solid GCP and preferably also GLP or GVP auditing experience from the pharmaceutical industry or from a CRO.
- the ability to work independently in an energetic and dynamic environment
- excellent communication skills, are fluent in English and are keen on working in a multicultural environment.
- strong organizational and administrative skills and you are a customer focused team player.
Further information about the position can be obtained by contracting Senior Director Tony Jørgensen via +45 28787201. Your application and CV in English should be sent as soon as possible but no later than 8 March 2018, as we will be reviewing incoming applications on an on-going basis. Please click here to apply.