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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 Nov 17
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)                

 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 more information please see our website: 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)

Other responsibilities may include:

  • Oversight of Quality Assurance Tracking System to ensure that reporting, tracking, trending and analysis of non-compliance issues is performed as required
  • Management, trending and analysis of internally and externally reported non-compliance issues
  • Interactions with various PRA functions to determine needs for process improvement, corrective and preventive actions and risk based auditing approach resulting from trending activities

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.

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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