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Sr Specialist QA - Netherlands  

Company managed [?] Still accepting applications
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Posted on : 01 May 2017

Project Description

Description:
  • Own, review and approve SOP’s and other GDP/GMP documentation and records (e.g. NCs and CAPAs), ensuring that Corporate, Site and Regulatory requirements are met.
  • Lead and participate in ABR internal and external audits as needed.
  • Support other company sites during European regulatory inspections by personal attendance as required.
  • Maintain a close contact and  familiarity with company Quality Systems and programs utilized at other company sites.
  • Provide guidance and direction to quality, production, Warehouse/Distribution and Supply Chain staff in regards to compliance with quality policies, standards and procedures.
  • Participate in global quality initiatives ensuring that ABR input is provided and leading ABR implementation activities.
  • Act as QA contact for all activities related to new product introductions and product life cycle management, including but not limited to change control review and approval.
  • Participate (lead) in various ABR projects and improvement efforts including (new) product launch teams. 
  • Act as owner for ABR quality programs and procedures
  • Act as Quality contact in case of regulatory inspections or various questions from regulatory bodies.
  • Perform activities as required per company procedures as QA staff, and in particular where the role of the QP is specified in the procedure.



Experience:
  • 8 years of professional experience in pharmaceutical environment (GMP)
  • Relevant experience in dealing with Quality systems such as Non Conformances, CAPA’s, Change Control, Complaints, Internal and External audits. 
  • Relevant experience related to interaction with regulatory bodies, including but not limited to for example IGZ, EMA, FDA, etc..


Skills:
  • Effective communication skills at multiple levels and areas (inside and outside of Quality)
  • Throrough decision making skills and  ability to apply risk based approach. 
  • Familiar with risk management tools such as FMEA, etc. 


Competencies:
  • Decision quality
  • Problem solving – making complex decisions
  • Compliance rule-following attitude with high degree of attention to detail.