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Compliance Expert - Belgium, Netherlands  

Company managed [?] Still accepting applications

Posted on : 22 April 2017

Project Description


Compliance Expert Responsibilities:
  • Ensuring a strong GMP compliance level within the SCM department resulting in Permanent Inspection Readiness. 
  • Maintaining and improving the processes and related procedures to comply with the latest GMP standards. This includes writing & improving of various SOP’s and instructions (part of the Quality Management System).
  • Ensuring that new regulations and guidelines (GMP) are effectively communicated and trained to all relevant personnel. 
  • Executing shop-floor visits to improve the compliance level by means of coaching and training in procedures, data integrity principles, root cause analyses etc.
  • Preparing and guiding internal and external inspections and audits including the follow-up as a result of potential improvements.
  • Coordinating Quality Notifications. Performing trend analysis to initiate & implement improvements.
  • Coordinating root cause investigations in case on non-compliance and developing sustained preventive actions (fe update of procedures, training of personnel) in close cooperation with the business. 
  • Using Lean Six Sigma techniques in order to improve way of working
  • Managing process changes in the global change management system for the manufacturing support center or service providers interfaces
  • Coordinating complaints from the manufacturing departments or customers. 
  • Monitoring the operational GMP compliance status by KPI’s and coordinating specific actions at the department and site-broad level
  • Participating in global or site-broad compliance improvement projects
  • Connecting to other GMP experts within the site or other sites to harmonize & improve way of working.
  • Maintaining and/or implementing a site-broad GMP standard. 



Requirements:
  • BSc or MSc in (Bio) Technology or equivalent qualification
  • At least 3-5 years of relevant GMP experience in a biotech, pharmaceutical or chemical manufacturing organization
  • Thorough knowledge of GMP and external regulations like FDA guidelines
  • Demonstrated ability to manage improvement projects (Lean 6-sigma experience/ belt certificate is preferred) 
  • Pro-active attitude with an improvement mindset and strong analytical skills; 
  • Ability to influence and communicate with all levels of the organization from shop floor to senior management; 
  • Leads by example and must have excellent communication skills with shop-floor personnel.
  • Experience with support of regulatory and corporate audits; 
  • Excellent writing and communication skills in Dutch and English.  



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.