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Quality Compliance Specialist Antwerp Belgium, Breda Netherlands,  

QBD (company)


Posted on : 12 April 2017

Project Description


Description:  
  • First point of contact for identification and alerting of potential deviations to department standard processes 
  • Ensure timely completion of Supply Chain non-conformances, investigations, CAPAs through the nonconformance procedures 
  • Support the customer service and transportation teams with a number of writing tasks including completion of Class 1 & 2 NC investigation reports 
  • Monitor and manage the NC-CAPA team workload for the department, including escalation when timelines for record completion are at risk 
  • Contribute, oversee, run and participate in root cause analysis, implementing improvements and corrective actions 
  • Perform trend analysis of non-conformance relating to Supply Chain 
  • Ensure investigations constantly reflect current requirements and expectations 
  • Participate in cross functional teams with colleagues from other departments to assess, communicate and manage information and performance via scorecards and meetings 
  • Perform tasks and participate on project teams assigned to assist in the timely completion of activities associated with the attainment of group, departmental, team and corporate goals 
  • Ensure flow of communication to stakeholders 
  • Develop strong working relationships with International Quality, departmental subject matter experts and managers 
  • Facilitate (chair) periodic quality management review meetings as well as cross-departmental (Regional Supply Chain/Security/International Quality) meetings addressing compliance/quality topics 
  • Author, own and manage Standard Operating Procedures for Europe Supply Chain organization in the documentation system 
  • Manage assigned change control tasks 
  • Identify improvement areas and partner to develop business cases  



Requirements:

  • Proactive, assertive, well organized person with an eye for detail possessing strong analytical and social skills 
  • Enthusiastic person willing to learn and grow position-specific skillset 
  • Strong knowledge of ERP system/GMP compliance 
  • Experience with electronic Quality Management systems 
  • Scientific & regulatory writing skills to produce reports in line with compliance requirements 
  • Exposure to root cause analysis and other investigation tools (5-whys etc.) 
  • Apply analytical thinking to evaluate and interpret complex situations/problems using multiple sources of information 
  • Excellent English verbal and written communication skills including technical writing, presentation and facilitation skills 
  • Experience with non-conformances, investigations, CAPAs 
  • Experience of authoring documents in a controlled document system 
  • Ability to evaluate complex compliance issues 
  • Ability to work in a fast paced environment with changing priorities 
  • Work under minimal direction 
  • Awareness of Change Control philosophy in the cGMP environment 
  • Understanding of the requirements of EU Good Distribution Practices 
  • Microsoft Office experience 
  • Strong data analysis skills 
  • Operational excellence mindset  



Minimum Requirements: 
  • Bachelor degree preferably in pharmaceutical studies 
  • Experience in (preferably) the pharmaceutical industry 
  • Strong cGMP and GDP knowledge 
  • Strong communication and presentation skills (verbal & written) 



Offer:
  • a young, dynamic company with a let s go for it mind-set, a no-nonsense approach, and a culture of openness and transparency
  • personal and professional development through guidance, education and knowledge sharing
  • a competence development model focused on your personal ambitions
  • an attractive salary package, including a variety of extralegal benefits such as a company car, fuel card, mobile phone, etc. 

Locations

Wilrijk BelgiumBreda Netherlands

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