Quality Laboratory Coordinator

Accreditation according to DIN 17025 and maintenance from the whole Laboratory Quality System. Organization and coordination of all forms of laboratory work associated with clinical studies.

Key Accountabilities:

• Introduction in study-relevant documents for laboratory

• Monitor and direction of adherence to internal quality standards in cooperation with Quality Management Determination of training need and organisation

• Analyze key risk indicators and investigate risk signals by performing, reporting and coordinating risk-based quality evaluations for assigned projects using dashboards, reports and other available tools

• Facilitate and drive the risk management process for laboratory using the available tools

• Facilitate identification, investigation and remediation of quality issues as assigned using available tools and methodologies. Provides oversight, transparency and tracking of quality issues for assigned studies

• Assist with preparations, conduct and response/action plan development for audits/inspections as assigned

• Partner with project teams to achieve and maintain inspection-ready state

• Identify areas for continuous improvement of the Quality Management System in laboratory by submitting feedback on processes, participating in process improvement initiatives as requested

• Maintain compliance with Parexel standards

• Participation in internal meetings and meeting of other departments as well as in meetings with the sponsors

• All laboratory tasks associated with planning, implementation and completion of clinical studies according to the study protocol and ICH/GCP guidelines

• Preparation of e.g. plasma, serum and urine samples during the single studies

• Preparation of all laboratory inhouse methods (e.g. ELISA, RT-PCR)

• Shipment of the prepared sample material and support Sample Laboratory Manager

• Independent handling, monitoring and maintenance of all laboratory devices

• Development and test of new examination methods

• Representation of the laboratory at clients QualificationsSkills

• Relevant experience of laboratory in the pharmaceutical industry and/or a research institute

• Laboratory experience

• Very good knowledge in English

• Computer knowledge (MS Word, MS Excel, Outlook)

• Management skills, organisational talent

• Ability to work under pressure and flexibility in working hours

• Knowledge of ICH-GCP, GCLP and IATA guidelines, PAREXEL internal standard and general operating Procedures

Education

• School-leaving certificate after secondary modern school (minimum requirement) or A-Level

• Terminated education as medical-technical laboratory assistant or similar qualification

• Desirable experience in Quality Management (e.g. QMB)