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Production Specialist Job - Netherlands  

Company managed [?] Still accepting applications

Posted on : 16 April 2017

Project Description

Description
  • The Integrated Process Team (IPT) Pharma Outbound is divided into 2 parts: Pharma production and Outbound.
  • The scope of Pharma Production contains:
    • Production, testing and release of Pharmaceutical FPU (Finished Product Unpacked)
    • Supporting activities: Planning, Maintenance & Reliability and Improvement


The position
  • Currently, we are looking for a Production Specialist level 2 for the Pharma Improvement team within the Pharma Outbound IPT. 
  • Reporting to the Improvement Lead, the Production Specialist plays a key role in ensuring that our products are manufactured in line with GMP guidelines and procedures.



Main tasks:
  • Supervise that the production processes in the IPT are executed in line with (GMP) guidelines, procedures and regulatory files.
  • Act as Subject Matter Expert on product quality related issues and advise the Qualified Person on product quality impact due to changes/deviations in production processes.
  • Evaluate consequences of external guidelines, as well as initiate and develop policies and procedures. 
  • Assess (incidental) deviations from approved policies and procedures and approve GMP related documents.
  • Initiate and develop proposals / business cases for (Quality) improvement projects including deliverables and planning for the development and implementation of proposed improvements, in consultation with IPT staff, Quality and external parties
  • Support the IPT regarding GMP inspections
  • Monitor and analyze data (e.g. system and batch data, annual reviews, performance indicators), write or review data evaluation reports
  • Possible task: SSO
  • Project management role:  Lead IPT-/site-wide projects
  • Act as lead in cross functional investigations
  • Affinity with MPS/Lean and ambition to develop



Qualifications
Desired skills & experience
  • Bachelor or academic degree in life sciences
  • More than 5 years experience in GMP/Quality related role
  • Strong analytical and problem solving skills.
  • Good interpersonal skills; personal leadership skills
  • Result oriented, initiative, proactive, team player+
  • Excellent oral and written skills in English and Dutch.



About Us:
  • Our company  is working to help the world be well. 
  • Through our medicines, vaccines, biologic therapies and animal health products, we work in more than 140 countries to deliver innovative health solutions to patients and animals. 
  • We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them.
  • Our company  has a workforce of almost 4500 in the Netherlands at three main sites.
  • Our employees are the key to our company’s success. 
  • We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.  
  • Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.