Posted to MedZilla on 8/19/2017


ProClinical

England, Technical Writer for ICP Risk Assessment QA_OB_12891-MZ


 
 

This Technical Writer, Risk Assessment job is an excellent opportunity to work for a global leader in biopharmaceuticals located in South East England. The company has been established for more than 150 years and is a major supplier to the NHS. 

Job Overview:

  • To complete paper based risk assessments for all drug products tested in the Sandwich hub.
  • To author the required documents in partnership with site project leads
  • To provide the scientific rationale for presence of ICH Q3D elements based on information gathered about the process, product storage and the product formulation and combine this with drug product testing and Permitted Daily Exposure limits for a definition of risk to a product family.

Job Responsibilities:

  • To develop, author and implement the necessary risk assessment documents to ensure the team are aligned with ICH Q3D guidance and Internal Quality Systems.
  • To work with the subject matter expert in the team and site project lead to gather and process all relevant documentation required for the risk assessment.
  • To work collaboratively with all team members, customers and stakeholders to deliver a dynamic paper based risk assessment fit for regulatory inspection.
  • To have experience and knowledge of ICP-MS for elemental analysis is preferred but not required

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 Owen Bach on +44 203 8261 330 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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