Microcoat Biotechnologie GmbH is a medium-sized enterprise located southwest of Munich. We offer a wide range of individual and specialized services for the diagnostic and pharmaceutical industries. Our Laboratory Service division provides qualified analytical services in the fields of companion diagnostics, biological safety, and clinical development to the pharmaceutical industry worldwide. Our services are offered as GLP, GCLP, GCP or exploratory studies.
To complete our quality assurance team we are looking for a
Quality Assurance specialist (m/f)
Job Functions/primary responsibilities include, but are not limited to:
Supervision of compliance, consistency and quality of QA processes.
Continuous improvement of our QA System according to best-in-class practices.
Establishment and implemenation of policies and/or procedures within the GLP/GC(L)P quality system to ensure consistency, transparency and thoroughness in the assessment of quality especially within pre-clinical and clinical research programs and activities.
Preparation, conduction and documentation of internal audits related to GLP/GC(L)P.
Hosting and participation of customer audits and regulatory authority inspections related to GLP/GC(L)P.
Provision of consultancy on quality/compliance/regulatory related issues according to latest regulatory requirements, industry standards and changes.
Review of plans, data and reports of preclinical- and clinical study analytics.
Education, Experience and Requirements
5+ years of relevant experience in QA within clinical research in a regulated environment.
B.Sc. or M.Sc. or equivalent education in Biology, Biochemistry or similar, or other scientific degree.
In-depth understanding of GLP and GCLP principles, data management, concepts, practices and standards in the EU, US and internationally.
Idealy, practical experiences in the interaction with regulatory agencies.
Writing and reviewing of SOPs and scientific reports.
Reliable, analytical, and structured working manner.
Assumption of tasks in a responsible manner, readiness of mind, learning aptitude, flexibility, and preciseness
Excellent verbal, written, and interpersonal communication skills in German and English.
Unlimited full time employment
Ambitious and miscellaneous function in a committed team
As a member of our team you will work in an open and target-oriented environment with the opportunity to contribute your ideas.
We are looking forward to your application – please apply by email which contains all application documents in one PDF-file. Please send your complete application documents (CV, certificates), including salary expectations and the earliest possible starting date to the following email address: HumanResources@microcoat.de
Microcoat Biotechnologie GmbH Abteilung Human Resources Am Neuland 3 82347 Bernried www.microcoat.de
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