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Quality Assurance Manager (DE) - Germany  

KCR (company)


Posted on : 08 March 2017

Project Description

Location: Berlin (office-based)   The duties associated with the role include:   Supervising and conducting internal and external audits Providing assistance in the area of preparation of sponsor audits and inspections Preparing reports from audits, along with suggestions of appropriate corrective actions Preparing, planning, performing and controlling the processes of CAPA implementation in response to audits (internal and external) Implementing company strategy, standards and metrics for QA activities Providing support and maintaining the organization of SOP system in KCR Maintaining full knowledge of all local policies, procedures and guidelines, FDA and European (EMA) and local regulations and guidelines Providing training sessions on topics related to quality and/ or compliance as individually assigned Evaluating and developing assigned Quality Assurance and Compliance Department staff   Requirements:   At least 3 years of experience as an auditor in medical/ pharmaceutical/ medical device/ CRO field, with relevant work experience in clinical research Very good understanding of industry standards and applicable GCP guidelines and FDA/EMA regulations Awareness of GMP and GLP regulations, basic knowledge of software validation process Ability to manage work schedule in accordance with priorities in changing environment Computer competency Fluency in English Sound judgement to evaluate discrepancies, make decisions and report findings Ability to produce quality reports and written documentation Ability to travel domestically and internationally approximately 50% of time in order to perform QA responsibilities and attend training sessions   If you wish to apply, please submit your CV using the button below.

Locations

Germany Berlin

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