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Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting With Heart®? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people With Heart®.

Quality Specialist I

Job ID 75863BR Berlin, Land Berlin, Germany
We are currently looking for a Quality Specialist I to be based in Germany. We offer 18 months contract with a possibility of extension. The Quality Specialist I will perform Quality Control tasks in depot and warehouse operations. This includes undertaking local quality management tasks as described in PAREXEL controlled documents. Please note there are no laboratories in EUDC and that the role relates to the following activities:
  • IPC for labelling and packaging
  • Incoming and outgoing goods control
  • The role also serves as a quality consultant to designated operational group(s) which includes:
  • Identification of process improvement opportunities
  • Process authoring and review, support for process re-engineering
  • Provide GxP and process expertise to designated operational group(s)
  • Contribution to the development of training materials as process subject matter expert
  • Support for identification, management and prevention of quality issues
  • Provide audit and inspection support and assist with the collection and reporting of quality metrics

Key Accountabilities:
  • Execute QC checks of Medicinal Products and other quality critical Clinical Trial Supplies during receipt, production and distribution
  • Provide support for Change Control management related to premises, equipment and processes in depots/warehouses
  • Support premise and equipment (P&E) maintenance and cleaning
  • Undertake local P&E Quality tasks as defined in PAREXEL procedures to cover local QA tasks
  • Perform review of Production Batch Records
  • Perform and support P&E qualification/validation activities
  • Provide audit and inspection support
  • Provide support for management of quality issues. Facilitate and advise on corrections, corrective and preventive actions related to designated quality issues
  • Perform Process Lead role for strategic accounts (Partnerships) and/or key accounts or provide process support to strategic accounts (Partnerships) and/or key accounts
  • International travel as needed upon request

Qualifications

Knowledge and Experience:
  • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent experience
  • Relevant experience in the Clinical Research field (pharmaceutical industry or CRO), clinical or medical experience or other relevant experience in the areas Logistics Quality Management (LQM) support preferred
  • Project management/technology/business operations experience, as appropriate, preferred
  • Knowledge of GxP regulations preferred
  • Training experience, as appropriate, preferred
  • English proficiency (written and oral) required; German and Chinese language skills desirable
  • Excellent interpersonal, verbal and written communication skills
  • Client-focused approach to work
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail and strong organizational skills
  • Ability to travel as needed for the position

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