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QA Specialist - Germany  

Company managed [?] Still accepting applications

Posted on : 05 July 2017

Project Description

Description:
  • The Quality Assurance Department (QA Research) is looking for a quality assurance professional (QA Specialist GMP) to support our team.
  • The successful candidate should have a scientific background and demonstrate a high level of understanding of the application of quality assurance and compliance monitoring in regulated as well as non-regulated areas. 
  • The QA Specialist will be responsible for:


Main tasks/responsibilities:
  • Monitor compliance of the Quality Control department at BN-M (GMP), e.g. perform audits, training of staff as well as review and approval of documentation such as validations, qualifications, SOPs, change requests and deviations. 
  • Perform audits of internal processes  as required by GMP (e.g. facility, process, raw data and documentation) 
  • Ensure BN-M compliance with relevant guidelines and regulations as  well as company procedures also in view of audits and inspections. 
  • Support compliance activities (e.g. hosting of authority inspections and client audits). 
  • Maintenance of adequate quality procedures and  guidance for non GxP regulated areas within R&D (BN Internal Basic Quality Standard). 
  • Training of staff on quality related issues 
 

Qualifications/requirements:
  • Considerable experience  of working within QA in a GMP regulated environment (including release testing); proficiency in other compliance disciplines desirable (e.g. GLP) 
  • Sound knowledge of EU and US regulations and guidelines (such as ICH, FDA CFR, AMG, AMWHV) 
  • Experience in and knowledge of drug development and manufacturing, GMP regulations and regulatory compliance. 
  • BSc / MSc or equivalent in a life science, experience with development of vaccines and biologics preferable 
  • Previous audit experience (supplier, laboratories, vendors) desirable 
  • Strong quality orientation including the ability to focus on details and adherence to standards 
  • Strong team player, self motivated 
  • Exemplary communication skills including an excellent command of English both written and spoken 
  • Willingness to travel as required 
 

The offer:
  • An exciting and challenging position within a motivated and experienced international team. 
  • Contribute to and gain experience from working in a forward looking, international biopharmaceutical company