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Quality Specialist Antwerp Belgium, Breda Netherlands,  

QBD (company)


Posted on : 09 May 2017

Project Description

Responsible for: 
  • Functional lead for the batch record review process
  • The execution of batch records review or incoming goods records review including correlating actions in other systems (PAS-X, SAP)
  • Acting and managing as a quality approver any product/material related events/deviations and connected CAPAs
  • Approving product/material related change requests
  • Provide support on the shop floor to the IPTs or CoE
  • Review PPQ and cleaning validation reports
  • Provide support to new product activities and improvement to existing products
  • PQR review
  • Support identifying the correct metrics and to improve the metrics
  • CR/CCO owner for all applicable chapters 



Requirements:
  • Master degree preferable in Biotechnology, Chemistry or relevant field
  • At least 5 years of relevant experience in the pharmaceutical industry
  • In depth knowledge of industry guidance and respective regulations of multiple areas like Quality (Management) Systems, Regulatory Affairs, Quality Agreements, Documentation, Inspection and Auditing
  • Technical knowledge in manufacturing/packaging processes and testing techniques
  • Technical writing, Root Cause Analysis, Failure Mode & Effect Analysis (FMEA), CAPA establishment and lean Six Sigma
  • Quality by Design, Process Analytical Technology, Utilities Qualification/Validation
  • Effective planning skills
  • Ability to convert quality mindset into practice and bring others on that same page
  • Computer literacy knowledge
  • Statistical knowledge
  • Strong focus on clients and end-user
  • Ability to work under minimum supervision
  • Team work oriented
  • Flawless Integrity Mindset
  • Excellent interpersonal and communication skills, oral and written (Dutch and English)
  • Experience with documentation system and SAP preferable 



Offer:
  • A young and dynamic company with a feel good culture, an a great openness and a no-nonsense approach
  • Real investment in people through education and fun events
  • A competence development model focused on your personal ambitions
  • An attractive salary package 

Locations

Wilrijk BelgiumBreda Netherlands

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