Quality Specialist I

ABOUT THIS ROLE

We are currently looking for a Quality Specialist Ito be based in our European Distribution Center (EUDC)based inSchönefeld, on the outskirts of Berlin.

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, this 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

Knowledge and 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
• German & English proficiency both written and oral
• 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

Education

• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent experience.

Language:

• Fluent in English both written and oral and basic German

Location

• Based on site at the Depot in Schoenefeld on the outskirts of Berlin