|Title:||Quality Assurance Auditor (m/f)|
|Job Status:||Part Time|
Celerion is the leading global provider of outsourced early clinical research services. Customers include the leading global pharmaceutical companies as well as a number of biotechnology and small to midsized pharmaceutical companies. Our focus is on the development of innovative pharmaceuticals with the goal of enabling companies to reach early decisions concerning which compounds to progress further into clinical development. Celerion provides these services through three clinical research units with over 600 beds located in the US and Europe. In addition, Celerion provides clinical research services through partnerships with other clinical research units in North America, Europe and Asia. Supporting our clinical work are two world class bioanalytical laboratories located in Europe and the US. Celerion is unique from other leading CROs in that our sole focus is on first-in-man studies to clinical proof-of-concept, as well as clinical pharmacology studies to support product labelling, in contrast to other leading CROs who provide services from discovery to the market.
- Early Clinical Research and studies required to support product labeling
- Data Management and Biometrics (modeling and simulation, study design and protocol development, clinical data management, biostatistics, PK/PD, medical writing and reporting)
- Bioanalytical Services (discovery to late stage services with capabilities in small and large drug, metabolite and biomarker molecules)
- Drug Development Services (Regulatory affairs and drug development consultancy)
- Global Clinical Development including global multi-site studies conducted outside of Celerion clinics
Celerion sites are located in North America, Europe and Asia as follows:
U.S. Lincoln, Nebraska; Phoenix, Arizona; Philadelphia, Pennsylvania
Canada Montreal, Quebec
Europe Belfast, Northern Ireland; Zurich, Switzerland; Vienna, Austria; Berlin, Germany; Paris, France
Asia Seoul, Korea; Singapore, Indonesia
For Vienna, Austria we a looking for a
Quality Assurance Auditor (m/f)
The Quality Assurance Auditor (QA Auditor) will assess and assure study, project, and process compliance with protocols, Celerion Standard Operating Procedures, and applicable regulations and guidelines through audits. Additionally, he/she will assist Process and Standards Management with Standard Operating Procedures review, documentation and training records. The area of Auditing is Good Clinical Practice.
Day-to-day Quality Assurance Activities:
- Carry out auditing of Line of Service (LOS) (Global Clinical Development (GCD) is a clinical operations department) study procedures, data, records and documentation to assure compliance with study protocols, procedures, and applicable regulatory requirements (laws and industry standards) and guidelines; report audit findings via QA audit reports; and determine acceptability of the responses and verify the corrections/corrective actions.
- Perform system audits and audits of study phases; report audit findings via QA audit reports; determine acceptability of the responses and verify the corrections/corrective actions.
- Review study conduct issues, deviations, investigations, and change control documentation; and assess acceptability of the content and documentation.
- Maintain QA files and QA audit reports.
- Interact with internal clients to discuss QA observations and study related issues; and maintain effective and professional working relationships within and across departments in relation to study projects.
- Perform other functions as assigned by quality management.
- Providing consultancy on Quality Management System(QMS) and Good Practice (GxP) topics
Quality Management System:
- Participate in the improvement initiatives intended to improve quality, compliance of study, project data and reports; effectiveness and efficiency of the processes.
- Detect Quality Issues and need for CAPAs, and assist quality management with the QI/CAPA process.
- Participate in the review and/or writing of SOPs and other controlled documents, as required
- Update/maintenance of Celerion SOP binders and training records
Client/Sponsor Audits and Regulatory Authority Inspections:
- Assist with the preparation for and hosting of client/sponsor audits and/or regulatory inspections.
Facility Based Audits (internal):
- Participate in the preparation and execution of internal Facility based audits.
- Assist in vendor management through conducting QA audits of current and potential vendors via questionnaires and remote auditing.
- Bachelor’s degree in science or similar
- 1 - 5 years quality experience
- 4+ years of pharmaceutical/device clinical research experience
- Working knowledge of applicable Line of Service (LOS) (GCD)/function regulations and guidances (GCP/cGLP/cGMP and 21CFRPart 11, regulations and related guidelines, as well as local regulatory authority regulations as required.
- Excellent oral and written communication skills in English and German; knowledge of other languages advantageous
- Ability to organize and manage multiple priorities
- Good time management skills
- Collaborative team player, open minded, ethical and culturally sensitive
- Adapts well to change, decisive, tenacious and versatile
- Logical, observant, perceptive and good listening skills
- Attention to detail, tactful, and diplomatic
- Computer literate
- Flexible and willing to travel on occasion
*Equivalent education and experience will be considered.
Position Location: office based in Vienna, Austria
Contract: Part-time (18hrs/week)
Start: As soon as possible
Effective January 1, 2016, Assign Clinical Research joined Celerion.
The minimum monthly salary for this position according the applicable collective agreement is EUR 915,04 gross (for 18hrs/week); overpayment depending on qualification and experience planned.