Übersicht

*Job Description*

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

*We are currently looking for a Quality Specialist I to be based in Germany.*

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:* 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
Education:* Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent experience
Skills:* English and German proficiency (written and oral) required
* Excellent interpersonal, verbal and written communication skills
* Client-focused approach to work
* Ability to work independently, takes initiative, and has a flexible approach with respect to work assignments and new learning
* Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail and strong organizational skills
* Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization
* IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions
* Ability to travel as needed for the position
* Ability to think and work globally and be culturally aware
*Why Work at Parexel*

*There are pivotal moments in every career:* Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That’s Parexel. We’re a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.