QA Auditor to CTC Clinical Trial Consultants AB

CTC Clinical Trial Consultants AB (CTC) is looking to recruit a QA Auditor to join the company.

CTC is a full-service CRO with focus on early phase clinical trials. Our mission is to facilitate clinical and translational research by providing our customers with cost-effective advice, conduct and reporting of clinical trials. We perform in-house clinical conduct at our first-in human (FIH) and Phase I-IV clinical research units in Uppsala and Linköping.

As a QA Auditor, you will be involved in clinical trial activities and perform internal and external audits. You will have an important role in managing the issue management, audit management and in continuous improvements of key activities at CTC. You will have the unique opportunity to be exposed to many different therapeutic areas and collaborate cross-functionally with CTC team members and external collaborators. For this role, we are looking for someone with relevant experience, who has analytical and organizational skills and enjoys a fast-paced and stimulating work environment with competent and dedicated colleagues. If this sounds interesting to you – come join us!
The position is full time and we welcome your application today!

JOB DESCRIPTION

As a clinical QA Auditor your main responsibilities include:
• Planning, conducting, and reporting on internal audits, and CTC vendor audits
• Responsible for Issue Managment System and CAPA system
• Liaise and build close relationships with departments across CTC and CTC external clients
• Host and manage customer audits and participate in inspections
• Participating in activities to ensure continuous improvement of key activities at CTC
• Support CTC managers and CTC staff, as well as CTC customers in quality and regulatory-related issues

QUALIFICATIONS

The right candidate fulfills the following qualifications:
• Minimum 3-5 year experience in Quality Assurance and GCP (good clinical practice) auditing
• A relevant degree or demonstrable equivalent professional experience
• Previous pharmaceutical industry experience
• Good knowledge in MS Office
• Good knowledge in written and spoken English and Swedish

PERSONAL SKILLS & ATTRIBUTES

To be succesful in this role you need to be or have:
• High ethical standards
• Excellent communication and collaboration skills
• Organised and able to meet deadlines
• Able to plan and prioritise work appropriately
• Good analytical skills
• Approachable, friendly and trustworthy
If you are ready to bring your skills and experience to this position we are ready to offer you an exciting and stimulating work place at a company with an exciting future ahead!

ABOUT THE COMPANY

CTC Clinical Trial Consultants AB (CTC) is a full-service CRO with focus on early phase clinical trials. Our mission is to facilitate clinical and translational research by providing our customers with cost-effective advice, conduct and reporting of clinical trials. We perform in-house clinical conduct at our first-in human (FIH) and Phase I-IV clinical research units in Uppsala and Linköping. Our clinics work in close collaboration with our Clinical Operations, Biometrics and Pharmacovigilance departments to provide a true full-service option to our customers.

Today, CTC has 80 fulltime employees. In addition, we have a large pool of clinical research nurses and clinical research physicians with long experience from clinical trials who are employed by the hour. Closely connected to CTC are a number of consultants and advisors who are experts in various therapeutic areas. Since 2011 CTC has successfully conducted over 250 industry sponsored clinical trials for start-up companies as well as for international pharmaceutical companies and CROs. Our track record includes, but is not limited to, FIH, PET/MR, exprt precision QT (EPQT), drug-drug and food interaction, biosimilar, bioequivalence and bioavailability, new drug delivery systems and Phase IIa studies. We also participate in international, multi-centre Phase III-IV studies. We conduct clinical trials on medicinal products, medical device, probiotics and ATMP. For more information, please visit: www.ctc-ab.se