PRAHS

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2017-42020

2017-42020

Title 
Associate Director GMP Quality Assurance
Job Locations 
-
Poland
Slovakia
Czech Republic
Hungary
RS
Bulgaria
Germany
United Kingdom
Netherlands
Russia
...
Posted Date 
9/19/2017

More information about this job

Overview

PRA Health Sciences is a Clinical Research Organisation experiencing exceptional growth globally. The people we employ are key to this growth.

 

We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA!

 

 

 

Responsibilities

We are currently recruiting an Associate Director Quality Assurance to provide oversight for EU GMP activities occurring within the Groningen, NL and IMP Logistics facilities (Belarus, Russia, Ukraine).

 

Responsibilities include 

  • Conduct and manage sponsor audits and inspection facilitation
  • Self inspections
  • Vendor audits
  • Internal process audits
  • Support GMP documentation review as needed (e.g. responses, annual testing, quality agreements, procedural documentation, deviations, CAPA, qualification, risk assessments)
  • Including the management of three regionally located auditors in Ukraine, Russia and Belarus

 

Support areas will be 

  • Pharmacy, country specific: QP sponsor batch review audits (xUS/xEU) accoring to GMP, GDP, GSP, Ph. Eur., USP
  • QC laboratory, country specific: QC release testing according to GLP, GMP, GSP
  • IMP Logistics, country specific: storage & distribution, re-labelling, returns & destruction, responsible person/pharmacist, customs clearance according to GMP, GDP, GSP
  • vendor audits, global: qualification of vendors (e.g. clinical packagers, drug depots, customs brokers, excipient/API/IMP manufacturers, medical supplies) according to GMP, GDP, GSP
  • Facilitation, global: clients audits/reg. inspections; clients, FDA, EMA, MHRA, local regulatory authorities according to GMP, GDP, GSP, USP, Ph. Eur., 21CFR1300 (DEA)

 

Qualifications

The position requires

  • 10 years industry experience
  • 6 years of GMP QA Manufacturing/production audit experience
  • Vendor Audit experience
  • Familiarity with GCP and CROs
  • Regulatory Authority Experience (EMA, MHRA)
  • Fluency in Russian and English
  • Ability to travel 30-35%

 

Preferred

  • ISO Auditor Certification
  • 5 years managerial experience
  • Expertise in GCPs
  • Experience working at a CROs
  • Aseptic/Sterile Experience

 

We require an undergraduate degree or its international equivalent from an accredited institution, preferrably science-related. An advanced degree is appreciated.

 

Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale.

 

Location: The position could be office- or home-based in Europe. 

 

Applicants from Russia: Please send your application directly to prarecruitmentrussia@prahs.com

 

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