PRAHS

Returning Candidate?

2017-42020

2017-42020

Title 
Associate Director of 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

As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 70+ such drugs.

 

At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.

 

At PRA, borders do not create boundaries.  PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals.  Our growing workforce is comprised of over 13,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.  

 

For further information please visit: www.prahs.com

Responsibilities

We are currently recruiting an Associate Director Quality Assurance to provide oversight for EU GMP activities occurring within the NL and IMP Logistics facilities.

 

To include

  • Sponsor Audit and Inspection Facilitation
  • Self Inspections
  • Vendor Audits
  • Internal Process Audits and support GMP documentation review as needed (e.g. Responses, Annual Testing, Quality Agreements, Procedural Documentation, Deviations, CAPA, Qualification, Risk Assessments)

 

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)
  • Fluent in Russian
  • 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.

 

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

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