Posted to MedZilla on 5/24/2017


ProClinical

Italy, Data Integrity Consultant QA_ND_11934-MZ


 
 

A well-known international pharmaceutical company with sites around the globe is looking to hire a Data Integrity Consultant. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology.

Job Responsibilities:

  • Drive a laboratory and manufacturing data integrity project
  • Define and write policies as well as implement assessments on multiple sites.
  • To provide compliance assessment and remediation services for manufacturing site for 21 CFR Part 11 Assessments, laboratory data integrity assessments and remediation & computer software validation assessments and remediation.
  • The scope of the project will be limited to laboratory instruments located in Process Transfer & Scale-up, Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Research & Development, Quality Control laboratories etc.

Role Requirements:

  • Holding a degree in Science or Engineering
  • 5-8 years of work experience in a regulated industry (preferably FDA-regulated biotech/pharmaceutical) industry.
  • Applicant must be knowledgeable about regulatory/compliance/validation issues, be self-motivated, intelligent and reliable.
  • Knowledge of PC computer OS (typically Windows), knowledge of Word and excel are mandatory.
  • Must have strong written and oral communication skills
  • Experience in writing technical documents, especially compliance and/or Validation/quality assurance documents and protocols will be desired.
  • In addition, applicant will be required to demonstrate experience and skill in writing technical reports.
  • Knowledge of FTIR, GC, KF, HPLC

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nick Dietz on +44203 3193 033 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


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