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Job Details

Senior Quality Specialist

Company: PAREXEL
Location: Schoenefeld, close to Berlin
Reference: 37873BR
Closing Date: 13 Dec 17
Type: Full Time
Salary (£): Negotiable
Benefits: competitive

Job Summary:

An exciting and rewarding opportunity has arisen to join our international team as a Senior Quality Specialist Location: Depot Schoenefeld, Berlin. Are you passionate about Quality Assurance in Medicinal Products? Are you a pharmacist, accredited in Germany? Lets get in touch!

Requirements:

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.

At PAREXEL, we believe that the power to work independently and intelligently should be yours every day.

Your ability to understand our clients’ needs and achieve quality results is critical to our reputation as one of the best clinical research organizations (CROs) in the world.

An exciting and rewarding opportunity has arisen to join our international team as a:

Senior Quality Specialist

Location: Depot Schoenefeld, Berlin. 

Key focus areas / Accountabilities:

  • Execute QC checks of Medicinal Products and other quality critical Clinical Trial Materials during receipt, production and distribution
  • Oversee all Quality Control activities in local depot/warehouse
  • Perform QC release of Medicinal Product batches and batches of other quality critical Clinical Trial Materials (CTM)
  • Approve Product Specifications and Master Batch Records
  • Perform and support P&E qualification/validation activities as appropriate
  • Oversee local Packaging, Labeling & Distribution (PLD) related change control procedures and quality issue (QI) reporting
  • Provide audit and inspection support as assigned
  • Closely co-operate with local Head of Production, (Sr.) Depot Coordinator and local QP (Qualified Person) or local RP (Responsible Pharmacist) to ensure smooth depot/warehouse operations
  • Closely co-operate with (Sr.) GMP Lead to ensure worldwide harmonization
  • International travel required of approx. 10%

 Qualifications

  • Relevant experience in the Clinical Research field (pharmaceutical industry or CRO), clinical or medical experience or other relevant experience in the areas Clinical Logistics Services QM support required
  • Aseptic manufacturing experience required.
  • Knowledge of GMP regulations required
  • Experience of working in a GxP regulated, global environment with focus on GMP required
  • Leadership/project management/technology/business operations experience, as appropriate, preferred
  • Training experience, as appropriate, required
  • Relevant experience in Quality Management preferred
  • Experience with primary and secondary manufacturing.

Apply for this job: Senior Quality Specialist

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
England
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site
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