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Job Details

ASSOCIATE DIRECTOR OF GMP QUALITY ASSURANCE - Europe

Company: PRA Health Sciences
Location: Europe
Reference: AB-2017-42020
Closing Date: 19 Feb 18
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary and Benefits

Job Summary:

An outstanding opportunity to join one of the world’s leading contract research organisations and be part of a dynamic and growing international company. Join PRA Health Sciences as a Associate Director of GMP Quality Assurance and help realize your career potential.

Requirements:

ASSOCIATE DIRECTOR OF GMP QUALITY ASSURANCE

Location: Europe (Poland, Slovakia, Czech Republic, Hungary, Serbia, Bulgaria, Netherlands, United Kingdom, Germany)                

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)

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.

Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.

For more information please visit our website: www.prahs.com

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

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

If you have any questions please email recruiteruk@prahs.com or call our recruitment department at +44 (0) 1189 213652

PRA Health Sciences is an Equal Opportunity Employer.  We welcome and encourage diversity in the workplace.

Apply for this job: ASSOCIATE DIRECTOR OF GMP QUALITY ASSURANCE - Europe

Contact Information:

Address:  Head Office
500 South Oak Way
Green Park
Reading
Berkshire
RG2 6AD
England
Tel:  +44 (118) 918 1000
Fax:  +44 (118) 918 1001
Website:  Visit Our Web Site

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