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Job Details

Qualified Person for our Depot in Schoenefeld (Berlin area)

Company: PAREXEL
Location: Depot Schoenefeld south of Berlin
Reference: 38755BR
Closing Date: 14 Dec 17
Type: Full Time
Salary (£): Negotiable
Benefits: Competitive

Job Summary:

An interesting opportunity has arisen in our Depot Schoenefeld for a Qualified Person in our Distribution Center.

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:

Qualified Person for our Distribution Center

Location: Depot Schoenefeld, Berlin. 

Key Responsibilities:

  • Medical Products manufactured within the European Union have been manufactured and checked within the boundaries of national law and the requirements of the Marketing Authorization (MA) or Clinical Trial Application for IMP
  • Product imported form 3rd countries were manufactured and tested as required by the applicable regulation
  • Certify in a register or equivalent document, as operations are carried out and before any release, that each production batch was manufactured and tested as required by the applicable regulation
  • QP release of Investigational Medicinal Products (IMP) as per Clinical Trial Regulations, in accordance with agreed protocols, the principles of International Conference on Harmonization, Good Clinical Practice and Good Manufacturing Practice. 
  • Provide guidance on technical and regulatory requirements for the conduct of clinical trial and advice on GxP issues
  • Ensuring correct procedures are followed and the process for assembly and supply of study medication (investigational medicinal products) for use in patients in clinical trial studies is controlled. 

Skills:

  • Good communication skills
  • Good organisational skills
  • Good attention to detail
  • Adaptability


Language Skills

  • German proficiency (written and oral) 
  • English proficiency (written and oral)


Knowledge and Experience:

  • Substantial post qualification experience within the Pharmaceutical Industry (Pharmacy, Regulatory Authority, Pharmaceutical Manufacturer)
  • 2 years of practical experience in a company authorized to manufacture medicinal products in the EU, covering qualitative analysis of medicinal products, quantitative analysis of active substances and testing and checking the quality of medicinal products
  • Experience with EU QP certification 
  • Experience with certification and release of IMP 
  • GMP / GCP auditing experience 
  • Regulatory Inspection experience

Education:

  • Fulfilment of qualification as per §15 AMG
  • PhD degree in a science, technology or industry related discipline, preferred 
  • Member of a recognized regulatory body e. g. Chamber of Pharmacist, (such as German Authority “Landesamt für Umwelt, Gesundheit und Verbraucherschutz – Land Brandenburg)

Apply for this job: Qualified Person for our Depot in Schoenefeld (Berlin area)

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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