PRAHS

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2017-42020

2017-42020

Title 
Associate Director / Manager 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/Manager 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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